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Federal Register Notice: FDA is making available a draft guidance for industry entitled Pregnancy, Lactation, and Reproductive Pot...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

Comments Sought on Supplement GMP Info

12/19/2013

Federal Register Notice: FDA is seeking public comment on the information collection provisions of FDA’s current good manufa...

Comments Sought on Tobacco Substantial Equivalence Requirements

12/19/2013

OMB OKs Info on Device ID

12/19/2013

Federal Register Notice: FDA’s collection of information entitled “Unique Device Identification System,” has bee...

OMB OKs Info on Cardiovascular Labeling

12/19/2013

Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on Hypertension Indication: D...

Info on Device Communications Sent to OMB

12/19/2013

Workshop on Endpoints on Intraocular Lenses

12/19/2013

Federal Register Notice: FDA will hold a public workshop 3/28/14 entitled “FDA/American Academy of Ophthalmology (AAO) Works...

FDA Modernizes Citizen Petition Regs to Include E-Submissions

12/19/2013

Federal Register Final rule: FDA is modernizing its administrative regulations on submitting citizen petitions to explicitly provi...