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FDA Corrects Notice on Outsourcing Facility Bulk Drug List

06/25/2015

Federal Register Notice: FDA is correcting a notice entitled “List of Bulk Drug Substances That May Be Used by an Outsourcin...

Guidance on Nonprescription Drug AERs

06/25/2015

Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry on Postmarketing Adverse Eve...

FDA Amends Animal Feed Regs for Bioengineered Safflower

06/22/2015

Federal Register Final rule: FDA is amending the regulations for food additives permitted in feed and drinking water of animals to...

FDA Permanently Debars Sarraf

06/22/2015

Federal Register Notice: FDA is issuing an order under the FD&C Act permanently debarring Anoushirvan Sarraf from providing servic...

FDA Debars Aminzada

06/22/2015

Federal Register Notice: FDA is issuing an order under the FD&C Act permanently debarring Mirwaiss Aminzada from providing service...

FDA Posts March, April NADA/ANADA Actions

06/16/2015

Federal Register Final rule: FDA is amending the animal drug regulations to reflect application-related actions for NADAs and ANAD...

OMB OKs Info on Animal Drug Bioequivalence

06/12/2015

Federal Register Notice: FDA’s collection of information entitled, “Waivers of In vivo Demonstration of Bioequivalence...

Guidance on Fetal Risk from APIs Administered to Males

06/12/2015

Federal Register Notice: FDA is making available a draft guidance for industry entitled Assessment of Male-Mediated Developmental ...

Guidance on Animal Food Additive Petitions.

06/12/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Recommendations for Preparation and Submission o...

FDA Seeks Comments on Electronic Positioning Chair Exemption

06/12/2015

Federal Register Notice: FDA has received a petition requesting exemption from the premarket notification requirements for an elec...