Office of Medical Policy
Vision
The Office of Medical Policy (OMP) anticipates, leads, and implements innovative policies that value all perspectives to advance responsible drug development and communication.
Mission
OMP advances the public health by addressing cross-cutting policy issues to facilitate the development and accurate communication of pharmaceuticals.
Connect With Us
Key Areas of Focus
OMP leads CDER’s clinical trial modernization and innovation initiatives, including the revision of the International Council for Hamonisation (ICH) E6(R3) Good Clinical Practice Guideline. This revision represents the first substantial modernization of good clinical practice since 1996.
Contact: CDEROMP@fda.hhs.gov | 301-796-2500
Guidances:
Resources:
OMP directs CDER's strategic initiatives on artificial intelligence (AI) use in drug development and regulatory science.
Leadership and Coordination:
- FDA AI Council membership: OMP co-represents CDER in this Agency-level coordinating body that leads AI implementation across FDA, addresses cross-cutting regulatory issues, and advances Agency-wide AI priorities.
- CDER AI Council co-leadership: OMP oversees AI-related activities throughout CDER and guides regulatory approaches to AI in drug development.
- Cross-Center collaboration: OMP collaborates with other FDA medical product Centers to ensure consistent regulatory approaches to AI across therapeutic areas.
- Global regulatory engagement: OMP participates in international discussions with global regulatory authorities to promote harmonized AI standards.
Contact: CDEROMP@fda.hhs.gov | 301-796-2500
Guidance:
Resources:
- AI for Drug Development
- FDA Digital Health and AI Glossary
- AI and Medical Products: How CBER, CDER, CDRH, and OCP Are Working Together
- Using AI and Machine Learning in the Development of Drug and Biological Products: Discussion Paper and Request for Feedback (PDF download)
- FDA Newsroom: AI and Machine Learning in Drug Development and Manufacturing
- AI in Drug and Biological Product Development: Hybrid Public Workshop
- CDER Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
For general AI-related publications, see Artificial Intelligence and Medical Products.
The Office of Prescription Drug Promotion (OPDP) protects the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. OPDP accomplishes this by:
- Providing written comments to pharmaceutical sponsors on proposed promotional communications to ensure clear and unambiguous communication of the laws and regulations related to prescription drug promotion.
- Reviewing complaints about alleged promotional violations (see Bad Ad Program).
- Initiating compliance letters for promotional communications that are false or misleading (see Warning Letters and Untitled Letters).
- Comparing the product labeling and promotional communications of closely related products to ensure that regulatory requirements are consistently and equitably applied.
- Traveling to major medical meetings and pharmaceutical conventions to monitor promotional exhibits and activities.
- Liaising with other FDA divisions on promotional issues.
Contact: CDER-OPDP-RPM@fda.hhs.gov | 301-796-1200
Resources:
OMP oversees both the Real-World Evidence Program, in coordination with CBER and the Oncology Center of Excellence, and the Real-World Evidence Subcommittee of CDER’s Medical Policy and Program Review Council. OMP also directs guidance development, demonstration (research) projects, engagements with domestic and international regulatory agencies and organizations, and related commitments under PDUFA VII, including the Advancing Real World Evidence Program.
Contact: CDER-RWE@fda.hhs.gov | 301-796-2500
Guidances:
- Use of Electronic Health Record Data in Clinical Investigations
- Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products
- Data Standards for Drug and Biological Product Submissions Containing Real-World Data
- Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products
- Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products
- Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
- Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
- Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
- Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs
Resources:
- Framework for FDA’s Real-World Evidence Program (PDF download)
- FDA Real-World Evidence Program
- Information on the Advancing Real World Evidence Program
- RWD and RWE-focused Demonstration Projects
OMP leads CDER’s policy work for digital health technologies that acquire remote data in clinical investigations. A digital health technology is a system that uses computing platforms, connectivity, software, and/or sensors to capture clinical features from trial participants. Digital health technologies can also be used to evaluate investigational medical products.
Contact: 301-796-2500
Guidance:
Resources:
- Digital Health Technologies for Drug Development
- Framework for the Use of Digital Health Technologies in Drug and Biological Product Development (PDF download)
OMP manages CDER’s policy efforts for incorporating decentralized elements in clinical trials. Decentralized elements allow trial-related activities to take place remotely at convenient locations for trial participants. Examples of these activities include telehealth visits with trial personnel or visits with local health care providers.
Contact: CDEROMP@fda.hhs.gov | 301-796-2500
Guidance:
OMP leads efforts regarding FDA’s regulations under 21 CFR part 11. Through policy development and communications, OMP helps sponsors, investigators, and other interested parties comply with 21 CFR part 11 in clinical investigations.
Contact: CDEROMP@fda.hhs.gov | 301-796-2500
Guidances:
- Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
- Part 11, Electronic Records; Electronic Signatures – Scope and Application
OMP develops policies and communications for investigational new drug application (IND) safety reporting. In this role, OMP helps sponsors and clinical investigators comply with the safety reporting requirements under 21 CFR 312.32, 312.64(b), and 312.66 for human drug and biological products that are being investigated under an IND.
Contact: CDEROMP@fda.hhs.gov | 301-796-2500
Guidances:
- Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
- Investigator Responsibilities – Safety Reporting for Investigational Drug and Devices
Resource:
OMP staff verify that patients have accurate and understandable information about their prescription drug products. To ensure that patients stay informed, FDA has proposed to amend its human prescription drug product labeling regulations for Medication Guides, which would provide concise, easy-to-understand information about prescription medicines.
Contact: CDEROMP@fda.hhs.gov | 301-796-2500
Resources:
- Medication Guides: Patient Medication Information – Proposed Rule
- Patient Medication Information (PMI)
- CDER Conversations: Patient Medication Information: A 2023 Proposed Rule to Help Patients Understand Their Prescription Medication Information
OMP collaborates with review staff to ensure a consistent approach across CDER when software is proposed or introduced for use with drug products. Sponsors are increasingly seeking to include software in their prescription drug applications or to distribute software for use with their prescription drugs. Prescription drug use-related software is disseminated by or on behalf of a drug sponsor and produces an output for end-users. This output supplements, explains, or textually relates to the sponsor’s drug products.
Contact: CDEROMP@fda.hhs.gov | 301-796-2500
Guidance:
OMP supports the repurposing of existing drugs for unmet medical needs, including the CURE ID program. CURE ID is a website and mobile application for individuals to report their treatment experiences with repurposed drugs. These reports help identify promising drugs for further study in adequate and well-controlled studies.
Contact: Heather Stone, heather.stone@fda.hhs.gov | 301-796-2274
Resources:
- CURE ID
- Repurposing Off-Patent Drugs: Research and Regulatory Challenges (video)
- CURE ID, A Tool for Clinicians to Report New Uses of Existing Drugs with Heather Stone and Dr. Marco Schito (transcript)
- CURE ID App Lets Clinicians Report Novel Uses of Existing Drugs
- CURE ID: Aggregating and Analyzing COVID-19 Treatments from EHRs and Registries Globally
OMP leads FDA’s efforts to support innovations in clinical trial design, including the use of point of care trials. Point of care trials may also be referred to as randomized clinical trials that are used in routine clinical practice.
Contact: Heather Stone, heather.stone@fda.hhs.gov | 301-796-2274
Guidance:
Resources:
- Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry; Availability
- Embedding Clinical Trials into Clinical Practice
- Real-World Evidence Webinar Series: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice (video)
OMP promotes the safe and effective use of prescription medications by collaborating throughout FDA to deliver effective and consistent patient labeling. Types of labeling include Patient Package Inserts, Medication Guides, and Instructions for Use. FDA requires certain drug and biological product application holders to make labeling changes based on new safety information that becomes available after approval. OMP staff provide edits and recommendations for Medication Guides and Patient Package Inserts to reflect labeling changes based on safety-related issues.
Contact: CDEROMP@fda.hhs.gov | 301-796-2500
Resource:
OMP leads CDER’s clinical trial modernization efforts to foster efficient sponsor oversight of clinical trial conduct in accordance with 21 CFR 312.50, 312.53(d), and 312.56(a). OMP’s policy initiatives build quality into trials upfront to ensure human subjects protection and data integrity for regulatory decision-making.
Contact: CDEROMP@fda.hhs.gov | 301-796-2500
Guidances:
- A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers
- Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring
Resources:
- Clinical Trials and Human Subject Protection
- Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches
OMP develops guidance documents and regulations for human drug development, human drug approval, and bioresearch monitoring in collaboration with corresponding program areas and coordinating committees. This policy development relates to promoting patient access to drugs, collecting data, and reporting in clinical trials and studies, as well as conducting clinical trials during public health emergencies. OMP leads the Expanded Access Coordinating Committee, which is an FDA-wide forum for discussing, recommending, and coordinating the implementation of expanded access policies and procedures.
Contact: CTconductquestions@fda.hhs.gov
Guidances:
- Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies
- Expedited Programs for Serious Conditions | Drugs and Biologics
- Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
Resource:
Search for FDA Guidance Documents
OMP Main Line: 301-796-2500
Office of Prescription Drug Promotion: 301-796-1200
Office of Medical Policy: CDEROMP@fda.hhs.gov
Office of Prescription Drug Promotion: CDER-OPDP-RPM@fda.hhs.gov
Real-World Evidence: CDER-RWE@fda.hhs.gov
Digital Health Technologies: DHTsforDrugDevelopment@fda.hhs.gov
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