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Upcoming Events
- Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – April 10-11, 2024
- FDA Drug Topics: Electronic Submission of Safety Reports – Ready for Primetime? - April 30, 2024
- Statistical Considerations for Premarketing Risk Assessment – May 16, 2024
| Summary | Audience | Media | Topic |
|---|---|---|---|
| The Current Status of Oral Phenylephrine as a Nasal Decongestant with Dr. Theresa Michele and Dr. Ilisa Bernstein | Health Care Professionals; Patients | Drug Regulatory Process; Drug Safety; OTC Drug Regulations | |
| Medication Health Fraud and Avoiding Medication Scams with Cynthia Ng | Health Care Professionals; Patients | Drug Regulatory Process; Drug Safety | |
| What does FDA regulate? | Health Care Professionals; Patients | Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; OTC Drug Regulations; Women’s Health | |
| Advancing Generic Drug Development: Translating Science to Approval 2023 | Health Care Professionals | Webinars | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| FDA Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Select Dosages for Combination Therapies and New Indications | Health Care Professionals; Patients | Webinars | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; IND |
| FDA/CDER Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Evaluate the Effects of Intrinsic and Extrinsic Factors | Health Care Professionals; Patients | Webinars | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Increasing the Efficiency of Biosimilar Development Programs 2023 | Health Care Professionals; Patients | Webinars | Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety |
| Second Annual FDA ASCO WORKSHOP on Getting the Dosage Right | Health Care Professionals; Patients | Webinars | Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety |
| CDER Conversation: Improving Medication Adherence and Patient Experience by Researching Patient Perceptions of Generic Drug | Health Care Professionals; Patients | Case Study; | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| Interchangeable Biosimilars | Health Care Professionals; Patients | Case Study; Videos | Biosimilars |
| Biological Products, Biosimilars Products, and Interchangeable Biosimilar Products | Health Care Professionals; Patients | Graphic | Biosimilars; Drug Regulatory Process; Drug Development |
| Biosimilar Manufacturing and Variation | Health Care Professionals; Patients | Graphic | Biosimilars; Drug Regulatory Process; Drug Development |
| Biosimilar Regulatory Approval Pathway | Health Care Professionals; Patients | Graphic | Biosimilars; Drug Regulatory Process; Drug Development |
| Generics and Biosimilars | Health Care Professionals; Patients | Graphic | Biosimilars; Drug Regulatory Process; Drug Development; Generic Drugs |
| What is a Biosimilar? | Health Care Professionals; Patients | Graphic | Biosimilars; Drug Regulatory Process; Drug Development |
| What is a Biosimilar? (Spanish) | Health Care Professionals; Patients | Graphic | Biosimilars; Drug Regulatory Process; Drug Development |
| Biosimilars Basics Infographic | Health Care Professionals; Patients | Infographics | Biosimilars; Generic Drugs |
| Conversations on Cancer: "What's on the Horizon: Future of Cancer Care" | Health Care Professionals; Patients; | Patients; Webinars | Cancer Drugs; Disease States |
| A Step Forward in the Treatment of Opioid and Alcohol Dependence with Dr. Iilun Murphy and Dr. Marta Sokolowska | Health Care Professionals; Patients | Podcasts | CE Credits; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Opioids |
| Clinical Trial Basics | Health Care Professionals | Podcasts | Biomarkers; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; IND; Women’s Health |
| Clinical Trial Basics with Dr. Robert Temple | Health Care Professionals; Patients | Podcasts | Disease States; Drug Regulatory Process; Drug Development; Drug Safety; IND; Biomarker; Women’s Health |
| Conversation on Paxlovid with Dr. John Farley | Health Care Professionals; Patients | Podcasts | COVID-19; Disease States; Drug Regulatory Process; Drug Development; Drug Safety |
| CURE ID, A Tool for Clinicians to Report New Uses of Existing Drugs with Heather Stone and Dr. Marco Schito | Health Care Professionals; Patients | Podcasts | CE Credits; Case Study; COVID-19; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch |
| Drug Information Soundcast in Clinical Oncology (D.I.S.C.O) | Health Care Professionals | Podcasts | Cancer Drugs; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women’s Health |
| Drug Shortages with CDR Emily Thakur | Health Care Professionals; Patients | Podcasts | CE Credits; COVID-19; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab) | Health Care Professionals; Patients | Podcasts | Disease States; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch |
| FDA approval of Augtyro (repotrectinib) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Epkinly (epcoritamab-bysp) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Fruzaqla (fruquintinib) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Jemperli (dostarlimab-gxly) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Keytruda (pembrolizumab) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Lynparza (Olaparib) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of OGSIVEO (nirogacestat) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Omisirge (omidubicel-onlv) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States, Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Polivy (polatuzumab vedotin-piiq) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E mutation | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Tibsovo (ivosidenib) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approval of Trodelvy (sacituzumab govitecan-hziy) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Women’s Health |
| FDA approval of Verzenio (abemaciclib) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Women’s Health |
| FDA approval of Zynyz (retifanlimab-dlwr) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approvals of Jaypirca (pirtobrutinib) and Orserdu (elacestrant) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Women’s Health |
| FDA approvals of Talvey and Elrexfio | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA approvals of Tukysa (tucatinib) | Health Care Professionals; Patients | Podcasts | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA Drug Safety Podcasts | Health Care Professionals | Podcasts | Drug Safety;Biosimilars; Cancer Drugs; Diabetes; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women’s Health |
| FDA Health Playbook | Health Care Professionals; Patients | Podcasts | Drug Safety; OTC Drug Regulations; MedWatch; Opioids |
| FDA Insight | Health Care Professionals; Patients; | Podcasts | Compounding; COVID-19; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Opioids; Women’s Health; OTC Drug Regulations |
| FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds | Health Care Professionals; Patients | Podcasts | Drug Development; Drug Regulatory Process; Drug Safety; IND |
| FDA takes steps to decrease barriers for overdose reversal agents with Dr. Marta Sokolowska | Health Care Professionals; Patients | Podcasts | CE Credits; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; OTC Drug Regulations |
| FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use | Health Care Professionals; Patients | Podcasts | Drug Development; Drug Regulatory Process; Drug Safety; MedWatch; Opioids |
| FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions | Health Care Professionals; Patients | Podcasts | Drug Regulatory Process; Drug Safety; MedWatch |
| FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) | Health Care Professionals; Patients | Podcasts | Drug Development; Drug Regulatory Process; Drug Safety; MedWatch |
| FDA’s Regulation of Dietary Supplements with Dr. Cara Welch | Health Care Professionals; Patients | Podcasts | CE Credits; Drug Development; Drug Regulatory Process; Drug Safety |
| FDA's Overdose Prevention Framework with Dr. Marta Sokolowska | Health Care Professionals; Patients | Podcasts | Disease States; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Opioids; Cancer Drugs |
| Generics-at-a-Glance with Dr. Sarah Ibrahim | Health Care Professionals; Patients | Podcasts | Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| Health Equity Forum Podcast | Health Care Professionals; Patients | Podcasts | COVID-19; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Diabetes; Women’s Health |
| Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products | Health Care Professionals; Patients | Podcasts | Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| MedWatch, Your Report Can Make a Difference with Dr. Gerald Dal Pan | Health Care Professionals | Podcasts | Disease States; Drug Development; Drug Regulatory Process; Drug Safety;Generic Drugs;MedWatch |
| Navigating the World of Online Pharmacies with CDR Lysette Deshields | Health Care Professionals; Patients | Podcasts | CE Credits; Drug Regulatory Process; Drug Safety |
| OMHHE Health Equity Forum Podcast - Toward Improving Race and Ethnicity Data in Healthcare | Health Care Professionals; Patients | Podcasts | Drug Development; Drug Regulatory Process |
| Q&A with FDA | Health Care Professionals | Podcasts | COVID-19; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch |
| The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development | Health Care Professionals; Patients | Podcasts | Biomarker; Biosimilars; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity | Health Care Professionals | Podcasts | Diabetes; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch |
| Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products | Health Care Professionals; Patients | Podcasts | Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Why Does the FDA Exist? | Health Care Professionals; Patients | Podcasts | Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Compounding Quality Center of Excellence Annual Conference 2023 | Health Care Professionals, Patients | Podcasts, Webinars | Compounding; COVID-19; Drug Development; Drug Regulatory Process; Drug Safety |
| Adverse Events Associated with Compounded Drugs from Outsourcing Facilities | Health Care Professionals | Podcasts; Webinars | Case Study; Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch |
| Biosimilars in the Real World: Perspectives for Staying Within the Scope of Care | Health Care Professionals | Podcasts; Webinars | Biosimilars; Cancer Drugs; CE Credits; Case Study; Diabetes; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch |
| Compounding Quality Center of Excellence Virtual Live Training | Health Care Professionals | Podcasts; Webinars | CE Credits; Case Study; Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch |
| Equity of Voices video series | Health Care Professionals; Patients | Podcasts; Webinars | Case Study; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch |
| Putting the Patient into Perspective: Strategies for Educating Patients about Biosimilars | Health Care Professionals | Podcasts; Webinars | Biosimilars; Cancer Drugs; CE Credits; Case Study; Diabetes; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women’s Health |
| Stability and Beyond Use Dates | Health Care Professionals | Podcasts; Webinars | CE Credits; Case Study; Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch; Case Study |
| Biosimilars Overview for Health Care Professionals | Health Care Professionals | Podcasts; Webinars | Biosimilars; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Biosimilars Resources | Health Care Professionals | Podcasts; Webinars | Biosimilars; Case Study; Drug Regulatory Process; Drug Development |
| Compounding Quality Center of Excellence On-Demand Training | Health Care Professionals | Podcasts; Webinars | CE Credits; Case Study; Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch |
| Conversations on Cancer: “Cancer Misinformation: Truth or Consequences” | Health Care Professionals; Patients | Podcasts; Webinars | Cancer Drugs; Disease States, Drug Development; Drug Regulatory Process; Drug Safety |
| Minority Health and Health Equity Webinars | Health Care Professionals; Patients | Podcasts; Webinars | Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Accelerating Access to Critical Therapies for ALS | Health Care Professionals; Patients | Videos | Biomarker; Disease States; Drug Development; Drug Regulatory Process |
| Accelerating Rare disease Cures (ARC) Program | Health Care Professionals; Patients | Videos | Biomarker; Disease States; Drug Development; Drug Regulatory Process |
| Biosimilar and Interchangeable Biologics: More Treatment Choices | Health Care Professionals; Patients | Videos | Biosimilars |
| Biosimilar Medications – What Health Care Providers Need to Know | Health Care Professionals; Patients | Videos | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| Biosimilar Medications — What Patients Need to Know | Health Care Professionals; Patients | Videos | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| Biosimilars Curriculum Materials for Health Care Degree Programs | Health Care Professionals; Patients | Videos | Biosimilars; Case Study; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs |
| Biosimilars Multimedia Education Materials | Health Care Professionals; Patients | Videos | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| Biosimilars Videos | Health Care Professionals | Videos | Drug Development; Biosimilars; Drug Regulatory Process |
| FDA Drug Info Rounds | Health Care Professionals | Videos | Drug Safety; MedWatch; IND; Drug Development; Drug Regulatory Process; Prescription Drug Promotion; Disease States; Registration and Listing; Generic Drugs |
| FDA Overview of Biosimilar Products | Health Care Professionals | Videos | Biosimilars;Drug Regulatory Process; Drug Development |
| FDA Review and Approval Process for Biosimilar Medications | Health Care Professionals; Patients | Videos | Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety |
| FDA's Biomarker Qualification Program | Videos | Biomarker; Drug Development | |
| GDUFA II Videos and Resources | Videos | Drug Development; Generic Drugs | |
| Overview of FDA role regulating and approving drugs | Health Care Professionals; Patients | Videos | Drug Development; Drug Regulatory Process; Drug Safety; MedWatch |
| Regulatory Science at CDER Videos | Videos | Drug Regulatory Process; Drug Development | |
| 14th Annual Sentinel Initiative Public Workshop | Health Care Professionals; Patients | Webinars | COVID-19; Disease States; Drug Regulatory Process; Drug Development; Drug Safety |
| 6 Tip-Offs to Rip-Offs: Don't Fall for Health Fraud Scams | Health Care Professionals; Patients | Webinars | Drug Safety |
| Achieving Data Quality and Integrity in Maximum Containment Laboratories | Health Care Professionals; Patients | Webinars | Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice | Health Care Professionals | Webinars | Case Study; Drug Development; Drug Regulatory Process; Drug Safety |
| Airflow | Health Care Professionals | Webinars | CE Credits; Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Application of Artificial Intelligence and Machine Learning for Precision Medicine | Health Care Professionals; Patients | Webinars | Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Areas of Customer Need for Outsourcing Facility Products | Health Care Professionals; Patients | Webinars | Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Aseptic Process Simulations (Media Fills) | Health Care Professionals | Webinars | CE Credits; Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Bench to Bedside: Integrating Sex and Gender to Improve Human Health | Health Care Professionals | Webinars | CE Credits; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Women's Health |
| BeSafeRx: Your Source for Online Pharmacy Information | Health Care Professionals; Patients | Webinars | Drug Safety |
| Biosimilars 102: Interchangeability, Extrapolation, and Immunogenicity - A Regulatory Process Primer (medscape.org) | Health Care Professionals | Webinars | Biosimilars; CE Credits; Drug Regulatory Process; Drug Development |
| Bridging Efficacy and Safety to the Obese | Health Care Professionals | Webinars | Biomarker;Cancer Drugs;Diabetes;Disease States;Drug Development;Drug Regulatory Process;Drug Safety;Generic Drugs;IND;MedWatch;Women's Health |
| CDER Webinars | Health Care Professionals | Webinars | Drug Regulatory Process; Drug Development; Generic Drugs; OTC Drug Regulations; Registration and Listing; Electronic Submissions; Biosimilars; Drug Safety; MedWatch; IND; Disease States; Prescription Drug Promotion; Cancer Drugs |
| Cleanroom In-person Course | Health Care Professionals | Webinars | Compounding; Drug Regulatory Process; Drug Development |
| Compounding Outsourcing Facilities Annual Study | Health Care Professionals; Patients | Webinars | Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Compounding Quality Center of Excellence Virtual Conference | Health Care Professionals; Patients | Webinars | Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Conversations on Cancer, Black History Month Program: “Real Talk: Our Stories as Black Oncologists at the FDA” | Health Care Professionals; Patients | Webinars | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Conversations on Cancer: “Seasons of Change: Oncology Careers” | Health Care Professionals; Patients | Webinars | Cancer Drugs; Disease States |
| Conversations on Cancer: Bringing Innovation to People Facing Cancer | Health Care Professionals; Patients | Webinars | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Conversations on Cancer: Cancer Disparities in Appalachia | Health Care Professionals; Patients | Webinars | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Conversations on Cancer: How Biotech Built a Blockbuster Cancer Drug | Health Care Professionals; Patients | Webinars | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Conversations on Cancer: Living with Metastatic Breast Cancer | Health Care Professionals; Patients | Webinars | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Conversations on Cancer: National Black Family Cancer Awareness Week, Engaging the Generations | Health Care Professionals; Patients | Webinars | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory Innovations | Health Care Professionals; Patients | Webinars | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Division of Drug Information Webinars | Health Care Professionals | Webinars | CE Credits; Drug Regulatory Process; Drug Development; Generic Drugs; OTC Drug Regulations; Biosimilars; Drug Safety; MedWatch; IND; Disease States; Prescription Drug Promotion; Cancer Drugs |
| Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation | Health Care Professionals | Webinars | CE Credits; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Women's Health |
| Environmental Monitoring In-person Course | Health Care Professionals | Webinars | CE Credits; Compounding; Drug Regulatory Process; Drug Development |
| FDA 101: An Overview of FDA's Regulatory Review and Research Activities | Health Care Professionals; Patients | Webinars | Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND; OTC Drug Regulations; Women’s Health |
| FDA Grand Rounds | Health Care Professionals; Patients | Webinars | COVID-19; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Generic Drugs; OTC Drug Regulations; Biosimilars; IND; Cancer Drugs; Biomarker; Women’s Health |
| FDA Rare Disease Day 2023 | Health Care Professionals; Patients | Webinars | Biomarker; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Health Fraud Scams | Health Care Professionals; Patients | Webinars | Drug Safety |
| Highlights in Oncofertility: Trends in an Emerging Field for Cancer Survivors | Health Care Professionals; Patients | Webinars | Cancer Drugs; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Women’s Health |
| Increasing the Efficiency of Biosimilar Development Programs | Health Care Professionals | Webinars | Biosimilars;Drug Regulatory Process; Drug Development |
| Insanitary Conditions and Sterility Assurance | Health Care Professionals | Webinars | Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Investigations and Corrective and Preventive Actions (CAPA) | Health Care Professionals | Webinars | Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Investigations and Corrective and Preventive Actions (CAPA) Virtual Course | Health Care Professionals | Webinars | Compounding; Drug Regulatory Process; Drug Development |
| Joint US FDA – Health Canada ICH Public Meeting | Health Care Professionals; Patients | Webinars | Disease States; Drug Development; Drug Regulatory Process; Drug Safety; IND |
| Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation | Health Care Professionals; Patients | Webinars | Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Women's Health |
| Maximizing Benefits and Minimizing Harms from Antibiotics | Health Care Professionals; Patients | Webinars | Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch |
| Medical Extended Reality: Applications and Challenges | Health Care Professionals; Patients | Webinars | Disease States; Drug Regulatory Process; Drug Development; Drug Safety |
| Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program | Health Care Professionals | Webinars | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender | Health Care Professionals; Patients | Webinars | Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Opioids; Women's Health |
| Outsourcing Facility Guide | Health Care Professionals | Webinars | Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Personnel Gowning in Sterile Drug Production | Health Care Professionals | Webinars | Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Pregnancy and Lactation Medication Information for the Healthcare Provider | Health Care Professionals | Webinars | CE Credits; Women’s Health; Disease States; Drug Regulatory Process; Drug Safety |
| Process Validation Virtual Course | Health Care Professionals | Webinars | CE Credits; Compounding; Drug Regulatory Process; Drug Development |
| Quality Management Systems Virtual Course | Health Care Professionals | Webinars | CE Credits; Compounding; Drug Regulatory Process; Drug Development |
| READDI for the next pandemic | Health Care Professionals | Webinars | Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Regulatory Framework for Human Drug Compounding | Health Care Professionals | Webinars | Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| State of Outsourcing Facility Sector and Possibilities for the Future | Health Care Professionals; Patients | Webinars | Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Sterile Drug Compounding In-person Course | Health Care Professionals | Webinars | CE Credits; Compounding; Drug Regulatory Process; Drug Development |
| Sterility Testing: Common Misconceptions | Health Care Professionals | Webinars | CE Credits; Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| Successfully Navigating the USPTO and FDA | Webinars | CE Credits; Drug Development; Drug Regulatory Process; Drug Safety; Registration and Listing | |
| Supplier/Contractor Qualification and Management | Health Care Professionals | Webinars | Compounding; Disease States; Drug Development; Drug Regulatory Process; Drug Safety |
| The History of FDA | Health Care Professionals | Webinars | Drug Development; Drug Regulatory Process; Drug Safety |
| Topics in Public Health | Health Care Professionals; Patients | Webinars | Biomarker; Biosimilars; Cancer Drugs; CE Credits; Case Study; Compounding; COVID-19; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND; MedWatch; Opioids; OTC Drug Regulations; Women's Health |
| Web-based Enduring Materials | Health Care Professionals | Webinars | Biomarker; Biosimilars; Cancer Drugs; CE Credits; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND; MedWatch; Opioids; OTC Drug Regulations |
| Advancing Regulatory Science at FDA | Health Care Professionals; Patients | Biomarker; Disease States; Drug Development; Drug Regulatory Process | |
| Are you on a biologic medication? What you need to know about biosimilar treatment options | Health Care Professionals; Patients | Biosimilars; Disease States; Drug Development; Drug Regulatory Process; Drug Safety | |
| Biosimilar Basics | Patients | Biosimilars; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs | |
| Biosimilar Basics for Patients | Patients | Biosimilars; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs | |
| Biosimilares: Lo que los pacientes con diabetes deben saber | Patients | Biosimilars; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs | |
| Biosimilares: Lo que los pacientes deben saber | Patients | Biosimilars; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs | |
| Biosimilars 101: A Primer for Your Practice | Health Care Professionals | Biosimilars; Cancer Drugs; CE Credits; Case Study; Diabetes; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women’s Health | |
| Biosimilars Level 1: Foundational Concepts | Health Care Professionals | Biosimilars; Case Study Drug Regulatory Process; Drug Development | |
| Biosimilars Level 2: Regulatory and Scientific Concepts | Health Care Professionals | Biosimilars; Case Study Drug Regulatory Process; Drug Development | |
| Biosimilars Patient Materials | Patients | Biosimilars; Drug Regulatory Process; Drug Development; Disease States; Drug Safety | |
| Biosimilars: Are they the same quality? | Health Care Professionals; Patients | Biosimilars; Disease States; Drug Regulatory Process; Drug Development; Drug Safety | |
| Biosimilars: What Patients Need to Know | Patients | Biosimilars; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs | |
| Biosimilars: What Patients With Diabetes Need To Know | Patients | Biosimilars; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs | |
| Biosimillars Health Care Provider Materials | Health Care Professionals | Biosimilars; Drug Regulatory Process; Drug Development; Disease States; Drug Safety | |
| Conceptos básicos sobre los biosimilares | Patients | Biosimilars; Diabetes; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs | |
| C-Path Scientific Breakthrough Summit 2023 | Health Care Professionals | Drug Development; Drug Regulatory Process; Drug Safety | |
| Drug Approval Case Studies | Health Care Professionals; Patients | Case Study; Diabetes; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND | |
| Expanded Access with Dr. Jacqueline Corrigan-Curay | Health Care Professionals; Patients | CE Credits; Disease States; Drug Development; Drug Regulatory Process; Drug Safety; IND | |
| FDA MedWatch and Patient Safety | Health Care Professionals | MedWatch; Drug Safety | |
| FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond | Health Care Professionals | Drug Regulatory Process | |
| FDA's Work to Combat the COVID-19 Pandemic | Health Care Professionals; Patients | COVID-19; Disease States; Drug Development; Drug Regulatory Process; Drug Safety | |
| Health Fraud Product Database | Health Care Professionals; Patients | Drug Safety | |
| How to Use the Consumer Complaint System and MedWatch | Health Care Professionals; Patients | Drug Safety; MedWatch | |
| Incorporating Biosimilars Into the Management of Patients With Immunological Conditions | Health Care Professionals | Biosimilars; Cancer Drugs; CE Credits; Case Study; Diabetes; Disease States; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women’s Health | |
| Interchangeable Biological Products | Health Care Professionals; Patients | Biosimilars | |
| Leveraging Health Literacy and Patient Preferences to Reduce Hypoglycemia Events in Patients with Type 2 Diabetes | Health Care Professionals | Diabetes; Disease States | |
| Naltrexone Injection for Opioid Use Disorder - FDA’s Efforts to Reduce Medication Errors | Health Care Professionals; Patients | Drug Regulatory Process; Drug Safety; MedWatch; Opioids | |
| Reporting Unlawful Sales of Medical Products on the Internet | Health Care Professionals; Patients | Drug Safety | |
| Risk Evaluation and Mitigation Strategies (REMS) Program Part 1 | Health Care Professionals; Patients | Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs | |
| Risk Evaluation and Mitigation Strategies (REMS) Program Part 2 | Health Care Professionals; Patients | Disease States; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs | |
| Safe Opioid Disposal | Disease States; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Generic Drugs; Cancer Drugs; Opioids | ||
| SBIA Chronicles | Health Care Professionals | Drug Regulatory Process; Prescription Drug Promotion | |
| Successes and Opportunities in Modeling and Simulation for FDA | Health Care Professionals; Patients | Biomarker; Disease States; Drug Development; Drug Regulatory Process | |
| Summary Report for Biosimilars | Health Care Professionals; Patients | Biosimilars; Disease States; Drug Development; Drug Regulatory Process; Drug Safety | |
| The FDA Bad Ad Program and Prescription Drug Promotion | Health Care Professionals; Patients | Prescription Drug Promotion | |
| The FDA Process for Approving Generic Drugs | Health Care Professionals | Drug Regulatory Process; Drug Development; Generic Drugs | |
| Overcoming Reluctance and Enhancing Biosimilar Adoption | Health Care Professionals | Biosimilars; CE Credits; Drug Regulatory Process |
Additional Resources
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