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Draft Guidance on Effect of Medicare Law on Listed Drugs

11/04/2004

Federal Register Notice: FDA is making available a draft guidance for industry entitled Listed Drugs, 30-Month Stays, and Approval...

FDA Withdraws Class 3 for Iontophoresis Devices

11/04/2004

Federal Register Proposed rule: FDA is withdrawing the 8/22/00 proposed rule that would amend the physical medicine devices regula...

Comments Sought on Iontophoresis Device Reclassification

11/04/2004

Federal Register Notice: FDA seeks information and comments on the agency’s intent to reclassify iontophoresis devices curre...

Info on Radioactive Drug Research Sent to OMB

11/03/2004

Federal Register Notice: FDA’s proposed collection of information, “Radioactive Drug Research Committees” has be...

FDA Seeks Comments on AERs for Biologics

11/03/2004

Federal Register Notice: FDA is announcing an opportunity for public comment on the information collection requirements relating t...

Info on NADA Form Sent to OMB

11/03/2004

Federal Register Notice: FDA’s proposed collection of information, “New Animal Drug Application, Form 356 V — 21...

OMB OKs Info Labels on In Vitro Diagnostic Devices

11/03/2004

Federal Register Notice: FDA’s collection of information entitled “Recommended Glossary and Educational Outreach to Su...

FDA Sends Info on Medicated Feed CGMPs to OMB

11/03/2004

Federal Register Notice: FDA’s proposed collection of information, “Current Good Manufacturing Practice Regulations fo...

Draft Guidance on Pregnancy Pharmacokinetics

11/01/2004

Federal Register Notice: FDA is making available a draft guidance for industry entitled Draft Guidance for Industry on Pharmacokin...

FDA OKs Phoenix Scientific ANADA for Canine Parasites

10/25/2004

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