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OMB OKs Info on a New Drug Applicaton

06/16/2005

Federal Register Notice: FDA’s collection of information entitled “Application for FDA Approval to Market a New Drug&#...

Comments Sought on Unapproved/New Uses

06/16/2005

Federal Register Notice: FDA is soliciting comments on the reporting and recordkeeping requirements associated with disseminating ...

FDA Revises Regs for Agency Grants Supporting Scientific Meetings

06/16/2005

Federal Register Notice: FDA is revising the Request for Applications published in the 6/6/02 Federal Register for partial support...

Guidance on Drug Metabolite Safety

06/06/2005

Federal Register Notice: FDA is making available a draft guidance for industry entitled Safety Testing of Drug Metabolites. The gu...

List of CBER-Approved PMAs Published

06/03/2005

Federal Register Notice: FDA is publishing a list of PMAs that have been approved by CBER to inform the public about the availabil...

Animal Drug Sponsor Changed to Watson Labs

06/03/2005

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor's name from Steris Laborat...

Animal Drug Sponsor Changes to Virbac

06/03/2005

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for 16 approved new animal...

Guidance on Consumer Medication Info

05/26/2005

Federal Register Notice: FDA is making available a draft guidance entitled Useful Written Consumer Medication Information (CMI). C...

Zithromax 250 mg Not Withdrawn for S&E

05/20/2005

Federal Register Notice: FDA has determined that Pfizer’s Zithromax (azithromycin) 250-mg oral capsules were not withdrawn f...

Guidance Out on Pharmaceutical Excipients

05/19/2005

Federal Register Notice: FDA is making available a guidance for industry entitled Nonclinical Studies for the Safety Evaluation of...