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Federal Register Notice: FDA is making available a draft guidance for industry entitled Assessment of Male-Mediated Developmental ...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

Review Period Set for Xeljanz

06/12/2015

Federal Register Notice: FDA has determined the regulatory review period for Pfizer’s Xeljanz (tofacitinib citrate) is 3,947...

FDA Sends Info on Device Recall Authority to OMB

06/12/2015

Federal Register Notice: FDA’s proposed collection of information, “Medical Device Recall Authority — 21 CFR 810...

FDA Sends Info on Device Reclassification Petitions to OMB

06/12/2015

Federal Register Notice: FDA submits a proposed collection of information entitled “Reclassification Petitions for Medical D...

Guidance on Cell-Based Products for Animal Use

06/12/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Cell-Based Products for Animal Use. The document...