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Info on Orphan Products Sent to OMB

12/18/2014

Federal Register Notice: FDA’s proposed collection, “Draft Guidance for Industry, Researchers, Patient Groups, and Foo...

Guidance on Study Data E-Submissions

12/18/2014

Federal Register Notice: FDA is making available a guidance for industry: Providing Regulatory Submissions in Electronic Format &m...

Info on Biologic Cooperative Manufacturing Sent to OMB

12/18/2014

Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry: Cooperative Manufacturing A...

Guidance on E-Format Submissions Under FDCA 745A(a)

12/18/2014

Federal Register Notice: FDA is making available a guidance: Providing Regulatory Submissions in Electronic Format — Submiss...

FDA Corrects Notice on Commissioning of State/Local Officials

12/16/2014

Federal Register Notice: FDA is correcting a 12/8 Federal Register notice that misstated the effective date of the new system of r...

Info on Bioequivalence Data Submissions Sent to OMB

12/16/2014

Federal Register Notice: FDA’s proposed collection of information “Requirements for Submission of In Vivo Bioequivalen...

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Federal Register Notice: FDA is making available a draft guidance for industry entitled How to Obtain a Letter from FDA Stating th...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Federal Register Notice: FDA is making available a draft guidance for industry entitled Pregnancy, Lactation, and Reproductive Pot...