| CPG Sec. 440.100 Marketed New Drugs Without Approved NDAs and ANDAs |
09/21/2011 |
11/25/2020 |
|
| Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals |
03/22/2020 |
11/07/2023 |
|
| Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers |
05/17/2021 |
11/07/2023 |
|
| Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry |
04/09/2020 |
11/07/2023 |
|
| Marketed Unapproved Drugs -- Compliance Policy Guide |
04/09/2020 |
11/03/2023 |
|
| Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry |
03/04/2020 |
06/02/2023 |
|
| Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic* |
02/24/2022 |
05/11/2023 |
|
| Development of Abbreviated New Drug Applications During the COVID-19 Pandemic--Questions and Answers |
04/21/2021 |
05/11/2023 |
|
| Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency |
01/15/2021 |
05/11/2023 |
|
| Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry |
12/21/2020 |
05/11/2023 |
|
| Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency* |
09/10/2020 |
05/11/2023 |
|
| Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing* |
06/19/2020 |
05/11/2023 |
|
| Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency |
06/17/2020 |
05/11/2023 |
|
| Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications--Questions and Answers |
05/27/2020 |
05/11/2023 |
|
| Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency |
04/06/2020 |
05/11/2023 |
|
| Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
04/20/2020 |
05/11/2023 |
|
| Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency |
04/10/2020 |
05/11/2023 |
|
| Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency |
04/22/2020 |
05/11/2023 |
|
| Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency* |
06/08/2020 |
05/11/2023 |
|
| Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry |
03/04/2020 |
06/02/2023 |
|
| Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic* |
02/24/2022 |
05/11/2023 |
|
| Development of Abbreviated New Drug Applications During the COVID-19 Pandemic--Questions and Answers |
04/21/2021 |
05/11/2023 |
|
| Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency |
01/15/2021 |
05/11/2023 |
|
| Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry |
12/21/2020 |
05/11/2023 |
|
| Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency* |
09/10/2020 |
05/11/2023 |
|
| Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing* |
06/19/2020 |
05/11/2023 |
|
| Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency |
06/17/2020 |
05/11/2023 |
|
| Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications--Questions and Answers |
05/27/2020 |
05/11/2023 |
|
| Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency |
04/06/2020 |
05/11/2023 |
|
| Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
04/20/2020 |
05/11/2023 |
|
| Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency |
04/10/2020 |
05/11/2023 |
|
| Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency |
04/22/2020 |
05/11/2023 |
|
| Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency* |
06/08/2020 |
|
|
| Classifying Significant Postmarketing drug safety issues |
3/01/2012 |
4/20/2020 |
|
| Immunotoxicology Evaluation of Investigational New Drugs |
11/01/2002 |
2/19/2020 |
|
| Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes |
12/1/2008 |
3/9/2020 |
|
| Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention |
3/1/2008 |
3/9/2020 |
|
| Target Product Profile -- A Strategic Development Process Tool |
3/30/2007 |
12/13/2019 |
|
| Qualification Process for Drug Development Tools |
1/6/2014 |
12/13/2019 |
|
| Acceptance of Foreign Clinical Studies |
3/01/2001 |
12/06/2019 |
|
| CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed |
3/01/1995 |
10/24/2019 |
|
| Analgesic Indications: Developing Drugs and Biological Products |
2/14/2014 |
08/23/2019 |
|
| Guidelines for the Clinical Evaluation of Hypnotic Drugs |
9/01/1997 |
08/23/2019 |
|
| Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information |
12/29/2016 |
07/22/2019 |
|
| Analgesic Indications: Developing Drug and Biological Products |
02/05/2014 |
06/20/2019 |
|
| Establishing Pregnancy Exposure Registries |
08/01/2002 |
05/08/2019 |
|
| In-Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Studies |
12/30/1997 |
06/10/1999 |
|
| Attachment D – Application, Product, and Establishment Fees: Common Issues and Their Resolution |
12/16/1994 |
11/08/2017 |
|
| New Drug Evaluation Guidance Document: Refusal to File |
07/12/1993 |
05/19/2017 |
|
| Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products; Availability |
02/26/1999 |
02/03/2000 |
|
| Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment |
05/16/2000 |
07/28/2010 |
|
| Part 11, Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records |
11/12/2002 |
02/04/2003 |
|
| Guideline for the Clinical Evaluation of Analgesic Drugs |
12/01/1992 |
08/05/2003 |
|
| Q1F: Stability Data Package for Registration Applications for Climactic Zones III and IV |
06/14/2002 |
11/21/2003 |
|
| Clinical Evaluation of Antacid Drugs |
04/01/1978 |
07/20/2004 |
|
| Clinical Evaluation of Antidiarrheal Drugs |
09/01/1977 |
07/20/2004 |
|
| Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs |
09/01/1977 |
07/20/2004 |
|
| Clinical Evaluation of Laxative Drugs |
04/01/1978 |
07/20/2004 |
|
| Clinical Evaluation of Radiopharmaceutical Drugs |
10/01/1981 |
07/20/2004 |
|
| FDA Requirements for Approval for Drugs to Treat Superficial Bladder Cancer |
06/01/1989 |
07/20/2004 |
|
| Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing |
12/30/2003 |
04/01/2011 |
|
| Preclinical Development of Antiviral Drugs |
11/01/1990 |
07/06/2005 |
|
| Preclinical Development of Immunomodulatory Drugs for Treatment of HIV Infection and Associated Disorders |
09/04/1992 |
12/29/2005 |
|
| Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence |
03/09/2000 |
08/12/2005 |
|
| Organization of an Abbreviated New Drug Application |
03/02/1999 |
11/18/2005 |
|
| BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Information |
02/01/2001 |
06/01/2006 |
|
| Drug Product: Chemistry, Manufacturing, and Controls Information |
01/01/2003 |
06/01/2006 |
|
| Drug Substance: Chemistry, Manufacturing, and Controls Information |
01/01/2004 |
06/01/2006 |
|
| Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application |
02/01/1987 |
06/01/2006 |
|
| Stability Testing of Drug Substances and Drug Products |
06/01/1998 |
06/01/2006 |
|
| Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptides |
11/01/1994 |
06/01/2006 |
|
| Submitting Documentation for the Stability of Human Drugs and Biologics |
02/01/1987 |
06/01/2006 |
|
| Providing Electronic Submissions in Electronic Format - ANDAs |
06/27/2002 |
09/29/2006 |
|
| Providing Electronic Submissions in Electronic Format - NDAs |
01/28/1999 |
09/29/2006 |
|
| Providing Regulatory Submissions in Electronic Format -- Annual Reports NDAs and ANDAs |
08/28/2003 |
09/29/2006 |
|
| Q1F: Stability Data Package for Registration Applications for Climactic Zones III and IV |
07/01/2004 |
07/05/2006 |
|
| Clinical Evaluation of Weight-Control Drugs |
09/01/1996 |
02/15/2007 |
|
| Anti-Inflammatory and Anti-Rheumatic Drugs (Adults and Children) |
04/01/1988 |
05/29/2008 |
|
| Labeling OTC Skin Protectant Drug Products |
06/04/2003 |
08/04/2008 |
|
| Guidelines for Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis |
02/11/2004 |
12/02/2009 |
|
| Continuous Marketing Applications: Pilot 1 – Reviewable Units for Fast Track Products under PDUFA |
10/06/2003 |
04/09/2010 |
|
| Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions during Development of Fast Track Products under PDUFA |
11/22/2004 |
04/09/2010 |
|
| Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions during Development of Fast Track Products under PDUFA; Paperwork Reduction Act Burden Statement |
06/17/2003 |
04/09/2010 |
|
| Clinical Evaluation of Lipid – Altering Agents |
08/14/1998 |
04/16/2010 |
|
| Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) |
12/04/2000 |
08/09/2010 |
|
| Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis) |
06/01/1998 |
10/17/2011 |
|
| Consumer-Directed Broadcast Advertising of Restricted Devices |
01/26/2004 |
08/09/2010 |
|
| Guideline on Validation of the Limulus Amebocyte Lysate Test |
12/01/1987 |
06/17/2011 |
|
| Guideline for Validation of Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices |
12/01/1987 |
07/08/2011 |
|
| Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review |
09/01/2009 |
09/21/2011 |
|
| Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling |
09/12/2006 |
02/21/2012 |
|
| In Vivo Drug Metabolism/Drug Interaction Studies - Studn Design, Data Analysis and Recommendations for Dosing and Labeling |
11/24/1999 |
02/21/2012 |
|
| Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro |
04/07/1997 |
02/21/2012 |
|
| Cholestyramine Powder In Vitro Bioequivalence |
01/15/1993 |
03/01/2012 |
|
| Consumer-Directed Broadcast Advertising Questions and Answers |
08/09/1999 |
09/08/2012 |
|
| Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing Medical Products for Treatment |
06/22/2010 |
06/27/2012 |
|
| Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients |
04/17/1998 |
08/07/2013 |
|
| Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment |
11/07/2003 |
08/07/2013 |
|
| Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution |
05/15/2001 |
08/07/2013 |
|
| Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by CDER, Beginning on January 1, 2000 |
12/22/1999 |
08/07/2013 |
|
| Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products |
02/20/1997 |
08/07/2013 |
|
| Empiric Therapy of Febrile Neutropenia; Developing Antimicrobial Drugs for Treatment |
07/22/1998 |
08/07/2013 |
|
| Lyme Disease—Developing Antimicrobial Drugs for Treatment |
07/22/1998 |
08/07/2013 |
|
| Secondary Bacterial Infections of Acute Bronchitis—Developing Antimicrobial Drugs for Treatment |
07/22/1998 |
08/07/2013 |
|
| Streptococcal Pharyngitis and Tonsillitis; Developing Antimicrobial Drugs for Treatment |
07/22/1998 |
08/07/2013 |
|
| Uncomplicated Urinary Tract Infections; Developing Antimicrobial Drugs for Treatment |
07/22/1998 |
08/07/2013 |
|
| Uncomplicated Gonorrhea—Developing Antimicrobial Drugs for Treatment |
07/22/1998 |
08/07/2013 |
|
| Vulvovaginal Candidiasis; Developing Antimicrobial Drugs for Treatment |
07/22/1998 |
08/07/2013 |
|
| Bacterial Vaginosis; Developing Antimicrobial Drugs for Treatment |
07/22/1998 |
08/07/2013 |
|
| Acute Bacterial Meningitis; Developing Antimicrobial Drugs for Treatment |
07/22/1998 |
08/07/2013 |
|
| Acute or Chronic Bacterial Prostatitis; Developing Antimicrobial Drugs for Treatment |
07/22/1998 |
08/07/2013 |
|
| Developing Antimicrobial Drugs - General Considerations for Clinical Trials |
07/22/1998 |
08/07/2013 |
|
| Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs For Treatment |
07/22/1998 |
08/07/2013 |
|
| Labeling Over-the-Counter Human Drug Products; Updating Labeling in ANDA's |
02/22/2001 |
08/07/2013 |
|
| Inhalation Drug Products Packaged in Semipermeable Container Closure Systems |
07/25/2002 |
08/07/2013 |
|
Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003-Questions and Answers
|
11/19/2004 |
08/07/2013 |
|
| Draft Guidance for Industry on Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications |
10/26/2000 |
08/07/2013 |
|
| Submission of Patent Information for Certain Old Antibiotics |
12/03/2008 |
08/07/2013 |
|
| Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act |
10/01/1999 |
08/07/2013 |
|
| Labeling OTC Human Drug Products - Submitting Requests for Exemptions and Deferrals |
12/19/2000 |
10/28/2013 |
|
| Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act |
11/23/1998 |
09/22/2008 |
|
| Providing Electronic Submissions in Electronic Format - ANDAs |
06/07/2002 |
06/11/2008 |
|
| Providing Electronic Submissions in Electronic Format - NDAs |
01/28/1999 |
06/11/2008 |
|
| Providing Regulatory Submissions in Electronic Format -- Annual Reports NDAs and ANDAs |
08/28/2003 |
06/11/2008 |
|
| Phenytoin/Phenytoin Sodium Capsules, Tablets and Suspension In Vivo Bioequivalence and In Vitro Dissolution Testing |
12/01/2005 |
06/05/2014 |
|
| Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis |
06/14/2000 |
04/07/2015 |
|
| Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications |
10/26/2000 |
04/07/2015 |
|
| Accelerated Approval Products —Submission of Promotional Materials |
03/26/1999 |
05/06/2015 |
|
| Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling |
01/01/2001 |
05/06/2015 |
|
| Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information |
09/05/2003 |
05/06/2015 |
|
| Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage |
02/21/2012 |
05/06/2015 |
|
| Providing Regulatory Submissions in Electronic Format - General Considerations |
10/01/2003 |
05/06/2015 |
|
| Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches |
12/16/2008 |
05/28/2015 |
|
| Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements |
02/09/2015 |
08/06/2015 |
|
| Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis |
06/07/2007 |
10/13/2015 |
|
| Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination |
03/09/2004 |
03/05/2016 |
|
| Exercise Induced Bronchospasms (EIB) Development of Drugs |
02/20/2002 |
05/10/2016 |
|
| Classifying Resubmissions in Response to Action Letters |
05/14/1998 |
05/27/2016 |
|
| Photosafety Testing |
05/07/2003 |
05/27/2016 |
|
| Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal, Food, Drug and Cosmetic Act |
12/04/2013 |
06/30/2016 |
|
| Aerosol Steroid Products Safety Information in Prescription Drug Advertising and Promotional Labeling |
01/12/1998 |
10/21/2016 |
|
| Assessment of Male-Mediated Developmental Risk for Pharmaceuticals |
06/12/2015 |
11/18/2016 |
|
| Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions; Final |
03/18/2002 |
09/22/2017 |
|
| Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions; Revision 1 |
01/27/2004 |
09/22/2017 |
|
| M4: Granularity Annex: Final |
10/01/2005 |
10/04/2017 |
|
| Drug Safety Information – FDA’s Communication to the Public -Draft |
03/08/2012 |
12/04/2017 |
|
| Drug Safety Information – FDA’s Communication to the Public - Final |
03/02/2007 |
12/04/2017 |
|
| Formal Meetings Between the FDA and Sponsors or Applicants - Final |
05/19/2009 |
12/27/2017 |
|
| Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products- Draft |
03/10/2015 |
12/27/2017 |
|
| Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices |
07/02/2009 |
12/13/2017 |
|
| Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment (Revised Draft) |
05/19/2016 |
03/26/2018 |
|
| Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment |
11/01/2006 |
04/19/2018 |
|
| Pediatric Oncology Studies In Response to a Written Request |
06/21/2000 |
04/30/2018 |
|
| Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants |
11/17/2015 |
06/04/2018 |
|
| Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommended Prescribing Information for Health Care Providers and Patient Labeling |
11/16/2005 |
06/07/2018 |
|
| Statistical Approaches to Evaluate Analytical Similarity Guidance for Industry |
09/21/2017 |
06/21/2018 |
|
| Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis |
07/15/1999 |
08/22/2018 |
|
