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Device User Fee Info Sent to OMB

05/21/2003

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

Comments Sought on Shipment of Non-sterile Devices

05/21/2003

Federal Register Notice: FDA is seeking comments on information collection requirements relating to shipment of non-sterile device...

OMB OKs Info on Effectiveness Studies

05/21/2003

Federal Register Notice: FDA’s collection of information entitled “New Drugs and Biological Drug Products; Evidence Ne...

Info on Samples/Protocols Sent to OMB

05/21/2003

Federal Register Notice: FDA has submitted its proposed collection of information entitled: “Request for Samples and Protoco...

FDA Reports on Postmarket Studies

05/21/2003

Federal Register Notice: FDA is reporting on the status of postmarketing study commitments made by sponsors of approved drug and b...

FDA OKs Intervet sNADA for Cattle Weight Gain

05/21/2003

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a supplemental new animal drug app...

Comment Period Extended for Dietary Supplements GMPs

05/19/2003

Federal Register Proposed rule: FDA is extending to 8/11 the comment period for a proposed rule published in the 3/13 Federal Regi...

Three Guidances on Medical Imaging Drugs and Biologics

05/19/2003

Federal Register Notice: FDA is making available three draft guidances for industry on Developing Medical Imaging Drug and Biologi...

Guidance Out on Dispute Resolutions for CVM

05/19/2003

Federal Register Notice: FDA is making available the draft guidance for industry entitled Dispute Resolution Procedures for Scienc...

Biological Response Modifiers Panel to Meet

05/19/2003

Federal Register Notice: FDA’s Biological Response Modifiers Advisory Committee will meet 6/9, from 1 p.m. to approximately ...