Drugs@FDA: approvals and reviews
Find covered US drug approvals, labelling and reviews; some biological product categories are outside its scope.
Reference link checked: 18 September 2026Pharmacy work guide
Regulation & registration
Authorities, authorisations and reference products
All fieldsStart with your task
- Identify the country, product type and regulatory route before comparing requirements.
- Distinguish guidance from binding decisions and verify document status and applicability.
Selected original references
FDA Orange Book data files
Official Orange Book source files; check the release date of the file used.
Reference link checked: 18 September 2026FDA Purple Book
US reference for licensed biological products, biosimilars and interchangeability information.
Reference link checked: 18 September 2026Egyptian Drug Authority
Official Egyptian authority gateway to available services, publications and decisions.
Reference link checked: 18 September 2026Algerian National Agency for Pharmaceutical Products
Algerian agency gateway; check the original document’s language, date and scope.
Reference link checked: 18 September 2026Australia’s Therapeutic Goods Administration
Australian authority gateway to medicine and device regulation and official safety information.
Reference link checked: 18 September 2026Japan’s Pharmaceuticals and Medical Devices Agency
The Japanese agency’s English gateway to reviews, safety and regulatory information.
Reference link checked: 18 September 2026Singapore HSA therapeutic products
Singapore authority information on therapeutic product registration, licensing and guidance.
Reference link checked: 18 September 2026This page guides access to sources; it is not a review of all their documents. Check version, jurisdiction and document status. A link-check date is not a document publication date.