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OMB OKs Info on Notice of Participation

06/02/2006

Federal Register Notice: FDA’s collection of information entitled "Notice of Participation" has been approved by the Office of Man...

OMB Approves Info on IND Regs

06/02/2006

Federal Register Notice: FDA’s collection of information entitled "Investigational New Drug Regulations" has been approved by the ...

FDA Submits Info on Rx Drug Marketing Act to OMB

06/02/2006

Federal Register Notice: FDA’s proposed collection of information, "Prescription Drug Marketing Act of 1987: Administrative Proced...

Comments Sought on Patent Info Reporting

06/02/2006

Federal Register Notice: FDA is seeking comments on the reporting requirements for submission and listing of patent information as...

Info on Blood Cell Separator Sent to OMB

06/02/2006

Federal Register Notice: FDA has submitted a proposed collection of information, Draft Guidance for Industry and FDA Staff on Clas...

Guidance Out on Ulcer and Burn Wounds

06/02/2006

Federal Register Notice: FDA is making available a guidance for industry entitled Chronic Cutaneous Ulcer and Burn Wounds — Develo...

ICH Guidance on Pharma Quality Risk Management

06/02/2006

Federal Register Notice: FDA is making available a guidance prepared under the auspices of the International Conference on Harmoni...

FDA OKs Schering Equine Oral Antibacterial

05/31/2006

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

FDA OKs Schering Equine Injectable Antibacterial

05/31/2006

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

Comments Sought on Clinical Holds Guidance

05/25/2006

Federal Register Notice: FDA is seeking public comment on the collection of information contained in a guidance for industry entit...