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...
FDA, CMS Extend Parallel Review Pilot
12/18/2013
Federal Register Notice: FDA and the Centers for Medicare and Medicaid Services have decided to extend the “Pilot Program fo...
Guidance on BE Studies for ANDA Pharmacokinetic Endpoints
12/05/2013
Guidance on BE Recommendations on Paliperidone Palmitate
12/05/2013
FDA Sends OTC Drug Labeling Info to OMB
12/05/2013
Federal Register Notice: FDA proposed collection of information, “Over-the-Counter Drugs; Labeling Requirements,” has ...
Comments Sought on Importer’s Entry Notice
11/27/2013
Comments Extended on Asthma Drug Bioequivalence
11/27/2013
Federal Register Notice: FDA is reopening the comment period for the notice of availability entitled Draft Guidance for Industry o...
