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Comments Sought on Premarket Notification

11/03/2006

Federal Register Notice: FDA is seeking comment on the proposed collection of certain information, "Premarket Notification &mdash...

FDA Sends Info on Device User Fees to OMB

11/03/2006

Federal Register Notice: FDA’s proposed collection of information, "Medical Device User Fee Cover Sheet; Form FDA 3601" has...

Comments Sought on Sample Electronic Products

11/03/2006

Federal Register Notice: FDA solicits comments on information collection requirements for reporting and recordkeeping, general an...

Workshop on Marketed, Unapproved Drugs

11/01/2006

Federal Register Notice: FDA is holding a public workshop 1/9/07 on issues related to the application process for seeking approva...

Guidance on Blood, Plasma Deviation Reporting

10/19/2006

Federal Register Notice: FDA is making available a document entitled Guidance for Industry: Biological Product Deviation Reportin...

Guidance on Biological Product Deviation Reporting

10/19/2006

Federal Register Notice: FDA is making available Guidance for Industry: Biological Product Deviation Reporting for Licensed Manuf...

Guidance on Antiretrovirals for HIV

10/18/2006

Federal Register Notice: FDA is making available a guidance for industry entitled Fixed Dose Combinations, Co-Packaged Drug Produ...

Pediatric Studies Out for 5 Products

10/18/2006

Federal Register Notice: FDA is making available summaries of medical and clinical pharmacology reviews of pediatric studies subm...

FDA, Duke Sign MOU on Cardiovascular Safety

10/16/2006

Federal Register Notice: FDA is providing notice of a memorandum of understanding between FDA and Duke University, on behalf of i...

Guidance on Investigating OOS Results

10/12/2006

Federal Register Notice: FDA is making available a guidance for industry entitled Investigating Out-of-Specification (OOS) Test R...