Product-Specific Guidances for Generic Drug Development Database More Information; Purple Book (database of FDA-licensed (approved) biological products, including biosimilar and...

2025年3月3日 · This database includes: medical device manufacturers registered with FDA and; medical devices listed with FDA; Note: Registration of a device establishment, assignment of a registration number,...

2023年10月31日 · FDA Industry Systems (FIS) was created to facilitate making submissions to the U.S. Food and Drug Administration (FDA), including registrations, listings, and other notifications. FIS has...

Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)

The Data Dashboard provides public FDA data in easy to use, visually accessible and understandable graphics.

2024年5月13日 · Describes FDA's OpenFDA initiative that creates easy access to public data and a new level of openness and accountability; ensure the privacy and security of public FDA data

2025年3月3日 · A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device...

The FDA's CDER database provides information on approved drugs and related resources.

Drugs@FDA allows you to search for official information about FDA approved innovator (brand name) and generic drugs and therapeutic biological products.

2021年2月24日 · A tool that provides visual representations and access to underlying data from FDA data sets on inspections, warning letters, seizures, injunctions, and recalls