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FDA Sends Collection of Info on Animal Drug AERs to OMB

12/16/2014

Federal Register Notice: FDA’s proposed collection of information “Records and Reports Concerning Experiences With App...

Guidance on Safety of BE Study Protocols

12/05/2014

Federal Register Notice: FDA is making available a draft guidance for industry entitled How to Obtain a Letter from FDA Stating th...

FDA Withdraws 23 NDAs, 68 ANDAs

12/05/2014

Federal Register Notice: FDA is withdrawing approval of 23 NDAs and 68 ANDAs from multiple applicants. The holders of the applicat...

Guidance on Pregnancy/Lactation Labeling for Drugs/Biologics

12/04/2014

Federal Register Notice: FDA is making available a draft guidance for industry entitled Pregnancy, Lactation, and Reproductive Pot...

FDA Changes Pregnancy Labeling of Drug/Biologics

12/04/2014

Federal Register Final rule: FDA is amending its regulations on the content and format of the “Pregnancy,” “Labo...

Docket Opened on E-Cigarettes

12/02/2014

Federal Register Notice: FDA’s Center for Tobacco Products is establishing a public docket in conjunction with the first pub...

Tobacco Collection of Info Sent to OMB

12/02/2014

Federal Register Notice: FDA’s proposed collection of information “Generic Clearance for the Collection of Quantitativ...

Guidance on OTC Acetaminophen Drugs and Skin Reactions

12/02/2014

Federal Register Notice: FDA is making available a draft guidance for industry entitled Recommended Warning for Over-the-Counter A...

Info on Supplement CGMPs Sent to OMB

12/02/2014

Federal Register Notice: FDA’s proposed collection of information “Current Good Manufacturing Practice in Manufacturin...

Guidance on Tracing Rx Drugs

12/02/2014

Federal Register Notice: FDA is making available a draft guidance for industry: DSCSA Standards for the Interoperable Exchange of ...