FDA Drug and Device Resources - ClinicalTrials.gov

U.S. Food and Drug Administration Resources on Drugs and Devices

Drug and Device Information From the Food and Drug Administration (FDA)

Drugs: Regulated by the FDA Center for Drug Evaluation and Research (CDER)
Medical Devices: Regulated by the FDA Center for Devices and Radiological Health (CDRH)
Vaccines, Blood & Biologics: Regulated by the FDA Center for Biologics Evaluation and Research (CBER)

Drug Action Packages

Drugs@FDA: Database of information about drug products approved by CDER
New Drug Applications with Supporting Documents (Biologics): List of drug products approved by CBER
Licensed Biological Products with Supporting Documents: List of biological products licensed by CBER

Device Approval Packages

Premarket Approval (PMA): Database of information about medical device PMAs approved by CDRH
Premarket Approvals and Humanitarian Device Exemptions with Supporting Documents: List of PMAs and humanitarian device exemptions approved by CBER
510(k) Premarket Notification: Database of information about device premarket notifications cleared by CDRH
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
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
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
Medical Device Safety: Lists of recent medical device recalls and other FDA safety communications
Safety & Availability (Biologics): Lists safety communications and availability of biological products information from CBER

Other Relevant Information

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
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
- Summaries of Medical and Clinical Pharmacology Reviews: As of December 13, 2019
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
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

This page last reviewed in May 2021