FDA Webview
X
about-us-banner

Articles

Home /Articles / FDA Federal Register Notices

FDA Submits Info on Device Inspections to OMB

11/03/2006

Federal Register Notice: FDA’s proposed collection of information, "Medical Devices: Inspection by Accredited Persons Progr...

FDA Publishes Modifications to Recognized Standards

11/03/2006

Federal Register Notice: FDA is releasing a publication containing modifications it is making to the list of standards the agency...

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...