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Federal Register Notice: FDA is reopening the comment period for the notice of availability entitled Draft Guidance for Industry o...
Comments Extended on Generic Drug User Fee Guidance
11/27/2013
Federal Register Notice: FDA is reopening the comment period to 12/11 for the Draft Guidance for Industry on Generic Drug User Fee...
Panel to Discuss REMS Communications
11/27/2013
Federal Register Notice: FDA’s Risk Communications Advisory Committee will meet 12/17 from 9 a.m. to 5 p.m. at the FDA White...
FDA Seeks Sponsors for Study Data Pilot
11/27/2013
Federal Register Notice: CDER and CBER are announcing a pilot project to evaluate the Clinical Data Interchange Standard Consortiu...
