U.S. Food and Drug Administration Resources on Drugs and Devices
Drug and Device Information From the Food and Drug Administration (FDA)
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Drugs: Regulated by the FDA Center for Drug Evaluation and Research (CDER)
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Medical Devices: Regulated by the FDA Center for Devices and Radiological Health (CDRH)
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Vaccines, Blood & Biologics: Regulated by the FDA Center for Biologics Evaluation and Research (CBER)
Drug Action Packages
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Drugs@FDA: Database of information about drug products approved by CDER
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New Drug Applications with Supporting Documents (Biologics): List of drug products approved by CBER
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Licensed Biological Products with Supporting Documents: List of biological products licensed by CBER
Device Approval Packages
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Premarket Approval (PMA): Database of information about medical device PMAs approved by CDRH
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Premarket Approvals and Humanitarian Device Exemptions with Supporting Documents: List of PMAs and humanitarian device exemptions approved by CBER
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510(k) Premarket Notification: Database of information about device premarket notifications cleared by CDRH
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Cleared 510(k) Submissions with Supporting Documents: List of 510(k) premarket notifications cleared by CBER
Drug and Device Safety Information
- Drug Safety Communications: Lists the most recent Drug Safety Communications from FDA and provides links to Early Communications, Follow-Up Early Communications, and Information for Healthcare Professional sheets
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MedWatch: The FDA Safety Information and Adverse Event Reporting Program: FDA gateway for clinically important safety information and for reporting serious problems with human medical products
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Postmarket Drug Safety Information for Patients and Providers: Links to postmarket drug safety information to improve transparency and communication with patients and health care providers
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Medical Device Safety: Lists of recent medical device recalls and other FDA safety communications
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Safety & Availability (Biologics): Lists safety communications and availability of biological products information from CBER
Other Relevant Information
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Committees & Meeting Materials: Database of FDA advisory committee meeting materials that may discuss the efficacy and safety of drugs and devices and summarize the results of clinical trials
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Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA): Links to medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under Section 505A(k)(1) of the Best Pharmaceuticals for Children Act of 2007 (BPCA) and pediatric assessments conducted under Section 505B(h)(1) of the Pediatric Research Equity Act of 2007 (PREA), as amended by FDAAA
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Summaries of Medical and Clinical Pharmacology Reviews: As of December 13, 2019
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Summaries of Medical and Clinical Pharmacology Reviews: As of December 13, 2019
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New Pediatric Labeling Information Database: Highlights key pediatric information from the studies submitted in response to pediatric legislative initiatives, including BPCA and PREA; provided by CDER
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Biologics PREA Reviews and Labeling Changes: Labeling changes and reviews of pediatric studies conducted under PREA, in accordance with Section 505B of the Federal Food, Drug, and Cosmetic Act, as amended by FDAAA; provided by CBER
- Pre-Notices for Potential Noncompliance: A table of Preliminary Notices of Noncompliance (Pre-Notices) issued by FDA informing a responsible party of an applicable clinical trial (ACT) regarding potential noncompliance with the legal requirements for registering and submitting results information to ClinicalTrials.gov. Pre-Notices are posted on a quarterly basis.
- ClinicalTrials.gov - Notices of Noncompliance and Civil Money Penalty Actions: A table of Notices of Noncompliance sent by FDA and the amount of civil money penalties assessed, if any, for each responsible party of an applicable clinical trial (ACT) or submitter listed. FDA also has the authority to issue a Notice of Noncompliance to a submitter who has failed to submit or knowingly submitted a false certification to FDA.
- ClinicalTrials.gov - a Three-Part [Video] Series: In a three-part webinar series, FDA provides a general overview of ClinicalTrials.gov and relevant definitions, laws, and regulations for complying with ClinicalTrials.gov registration and results information submission requirements. These presentations were part of the 2023 CDER Small Business and Industry Assistance Webinars and Conferences.
This page last reviewed in November 2023