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Comments Sought on Bar Code Requirements

07/24/2006

Federal Register Notice: FDA is seeking comments on the bar code label requirements for human drug and biological products. Commen...

Comments Sought on Dietary Supplement Regs

07/24/2006

Federal Register Notice: FDA seeks comments on the information collection provisions of the regulation requiring manufacturers, pa...

Comments Sought on Fast Track Product Feedback

07/24/2006

Federal Register Notice: FDA is seeking comments on the information collection contained in the guidance for industry on Continuou...

Panel on NDAs for Schizophrenia, Major Depressive Disorder

07/20/2006

Federal Register Notice: FDA’s Psychopharmacologic Drugs Advisory Committee will be meet 9/7-8, from 8 a.m. to 5 p.m. at the Hilto...

Panel to Discuss Adeza’s Gestiva

07/20/2006

Federal Register Notice: FDA’s Advisory Committee for Reproductive Health Drugs will meet 8/29, from 8 a.m. to 5:30 p.m. at the Hi...

Joint Committees to Discuss Levothyroxine

07/19/2006

Federal Register Notice: FDA will hold a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Advisory Com...

OMB Approves Info on Importer’s Entry Notice

06/30/2006

Federal Register Notice: FDA’s collection of information, "Importer's Entry Notice" has been approved by the Office of Management ...

New List of Recognized Standards

06/23/2006

Federal Register Notice: FDA is publishing "Modifications to the List of Recognized Standards, Recognition List Number: 015" for u...

Guidance on PMA Manufacturing Section

06/19/2006

Federal Register Notice: FDA is making available a draft guidance, The Review and Inspection of Premarket Approval Application Man...

FDA Sets Review Period for Takeda’s Rozerem

06/19/2006

Federal Register Notice: FDA has determined the regulatory review period for Takeda Pharmaceutical’s Rozerem is 2,224 days for ext...