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Panel to Discuss Provigil for ADHD

02/01/2006

Federal Register Notice: FDA’s Psychopharmacologic Drugs Advisory Committee will meet 3/23 from 8 a.m. to 5 p.m. at the Hilton Was...

Review Period Set for Spiriva Handihaler

01/27/2006

Federal Register Notice: FDA has determined the regulatory review period for the extension of a patent that claims the human drug ...

Oncologic Drugs Panel Meeting Date Changed

01/27/2006

Federal Register Notice: FDA is amending the 1/6 notice of meeting of the Oncologic Drugs Advisory Committee to change the date of...

Device Harmonization Study Documents Released

01/25/2006

Federal Register Notice: FDA is making available several proposed and final documents that have been prepared by Study Groups 1, 2...

Info on Exports Sent to OMB

01/25/2006

Federal Register Notice: FDA’s proposed collection of information, "Export of FDA Regulated Products — Export Certificates," has b...

Info on Blood Establishment Registration Sent to OMB

01/25/2006

Federal Register Notice: FDA has submitted a proposed collection of information, "Blood Establishment Registration and Product Lis...

FDA Withdraws 43 Able Labs ANDAs

01/19/2006

Federal Register Notice: FDA is withdrawing approval of 43 ANDAs held by Able Laboratories, Inc. because the drug products are no ...

Celestone Products Not Withdrawn for S&E

01/12/2006

Federal Register Notice: FDA has determined that two drug products — Celestone Soluspan (betamethasone sodium phosphate and betame...

FDA, Canada Share Software Tool

01/12/2006

Federal Register Notice: FDA is providing notice of a protocol on the sharing of the Phonetic and Orthographic Computer Analysis T...

Guidance on Formal Dispute Resolutions

01/12/2006

Federal Register Notice: FDA is making available a guidance for industry entitled Formal Dispute Resolution: Scientific and Techni...