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Latest posts
Last updated 2 days ago
Compounding and the FDA: Questions and Answers
2 days ago
Creating a medication tailored to the needs of an individual patient. FDA...
40th Anniversary of the Generic Drug Approval Pathway
2 days ago
In this CDER Conversation, Darby Kozak, PhD, deputy director for CDER’s Office...
Rulemaking History for OTC Sunscreen Drug Products
2 days ago
Rulemaking History for OTC Sunscreen Drug Products
Compounding Information for States
2 days ago
FDA collaborates with state officials in a variety of ways, including by...
Generic Drugs
2 days ago
Understanding generic drugs: Consumer-friendly information on the safe and effective use of...
Approvals & Reports
2 days ago
FDA publishes a list of first-time approvals to manufacture generic drugs and...
Industry Resources
2 days ago
Information to assist the drug manufacturing industry in the development of generic...
Overview & Basics
2 days ago
Generic medicine facts, questions and answers, and FDA review and approval process.
What Is the Approval Process for Generic Drugs?
2 days ago
Overview of the FDA review and approval process for generic drugs
Generic Drugs: Questions & Answers
2 days ago
A generic drug is a medication created to be the same as...
FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development
2 days ago
FDA published a new batch of draft product-specific guidances (PSGs) for developing...