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Guidance on Combo Product User Fees

09/28/2004

Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry and FDA Staff: Application User F...

Review Period Set for Reyataz

09/28/2004

Federal Register Notice: FDA has determined that the regulatory review period for Novartis Corp.’s Reyataz (atazanavir sulfa...

OMB OKs Info on Health Survey

09/28/2004

Federal Register Notice: FDA’s collection of information entitled “Health and Diet Survey — 2004 Supplement̶...

Review Period Set for Kineret

09/28/2004

Federal Register Notice: FDA has determined that the regulatory review period for Amgen’s Kineret (anakinra) is 4,101 days f...

Review Period Set for Visudyne

09/28/2004

Federal Register Notice: FDA has determined that the regulatory review period for Visudyne (verteporfin) is 3,194 days for extendi...

List of Exceptions for Blood Products

09/28/2004

Federal Register Notice: FDA is announcing the availability of a cumulative list of exceptions and alternative procedures to requi...

Public Meeting on MDUFMA

09/28/2004

Federal Register Notice: FDA will hold a public meeting 11/18: “Second Annual Stakeholder Meeting on the Implementation of t...

FDA Approves Merial’s Eqvalan for 4 New Horse Parasites

09/24/2004

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

Beta-Glucan Assay into Class II

09/23/2004

Federal Register Notice: FDA is classifying the beta-glucan serological reagent device into Class II (special controls) and is mak...

CBER Site Visit Training Program Launched

09/23/2004

Federal Register Notice: CBER is initiating a Regulatory Site Visit Training Program to give the Center regulatory review staff, c...