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ICH Guidance on the Pharmaceutical Quality System

07/13/2007

Federal Register Notice: FDA is making available a draft guidance entitled Q10 Pharmaceutical Quality System prepared under the au...

Comments Sought on IRB Info

06/28/2007

Federal Register Notice: FDA is seeking public comment on its proposed collection of information, “Institutional Review Boar...

OMB Approves Info on General Licensing

06/28/2007

Federal Register Notice: FDA’s collection of information, “General Licensing Provisions: Biologics License Application...

Comments Sought on PMA Requirements

06/28/2007

Federal Register Notice: FDA solicits comments on information collection requirements for premarket approval of medical devices, &...

Nominations Sought for Allergenic Products Panel

06/28/2007

Federal Register Notice: FDA is requesting that any industry organizations interested in participating in the selection of a non-v...

Hearing Opportunity for NDA Withdrawal Proposal

06/28/2007

Federal Register Notice: FDA is announcing an opportunity to request a hearing on the agency's proposal to withdraw approval of si...

Committees to Hear iPLEDGE Briefing

06/28/2007

Federal Register Notice: FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee and the Drug Safety and Risk Management ...

GMP Rule for Supplements

06/25/2007

Federal Register Final rule: FDA is issuing a final rule on current good manufacturing practice (CGMPs) for dietary supplements. I...

Requesting Exemption from Supplements GMP Rule

06/25/2007

Federal Register Interim final rule: FDA is issuing an interim final rule that sets forth a procedure for requesting an exemption ...

Info on Special Protocol Assessment Sent to OMB

06/22/2007

Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry on Special Protocol Assessme...