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This guidance discusses the information to be submitted by device manufacturers regarding medical device sterility in 510(k) submissions for sterile devices.

Reformulating Drug Products That Contain Carbomers Manufactured With Benzene

Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and Answers

Upper Makefield mother sentenced to life in prison for killing her young sons

Rare Diseases: Considerations for the Development of Drugs and Biological Products

This guidance assists those interested in pursuing FDA approval of new animal drugs intended for use in minor species or for minor uses in major species. It outlines the basic requirements and special considerations, as well as available incentives to encourage development of these drugs.

Guidance for Industry

Guidance for Industry

Guidance for Industry

This guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.