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Guidance on CGMPs for Combination Products

10/04/2004

Federal Register Notice: FDA is making available a draft guidance for industry entitled Current Good Manufacturing Practices for C...

Guidance on Quality Systems Approach to Drug GMPs

10/04/2004

Federal Register Notice: FDA is making available a draft guidance for industry entitled Quality Systems Approach to Pharmaceutical...

FDA Releases Modifications to Device Consensus Standards

10/04/2004

Federal Register Notice: FDA is releasing a ("http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0443-gdl0001.pdf") , Modifications to th...

Clinical Pharmacology Subcommittee Will Meet

10/04/2004

Federal Register Notice: FDA’s Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science will ...

FDA OKs Merial sNADA for Ivermectin in Horses

10/04/2004

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

FDA Requires PMA or PDP for Hip Joint Prosthesis

10/04/2004

Federal Register Final rule: FDA is issuing a final rule to require the filing of a premarket approval application (PMA) or a noti...

OMB OKS Info on Rapid Response Surveys

09/29/2004

Federal Register Notice: FDA’s collection of information entitled “Generic Food and Drug Administration Rapid Response...

Review Period Set for Dermagraft

09/29/2004

Federal Register Notice: FDA has determined that the regulatory review period for Advanced Tissue Sciences’ Dermagraft is 4,...

OMB OKs Info on Device Pilot

09/29/2004

Federal Register Notice: FDA’s collection of information entitled “Adverse Event Pilot Program for Medical Devices'' h...

Animal Drug User Fee Guidance

09/28/2004

Federal Register Notice: FDA is making available a draft guidance entitled Guidance For Industry: Animal Drug Sponsor Fees Under t...