FDA Webview
X
about-us-banner

Articles

Home /Articles / FDA Federal Register Notices

Guidance on Data Retention on Withdrawn Trial Participants

12/01/2008

Federal Register Notice: FDA is making available a guidance, Data Retention When Subjects Withdraw from FDA-Regulated Clinical Tri...

FDA Revokes Cephalosporin Prohibition

11/26/2008

Federal Register Final rule: FDA is revoking the order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food...

Guidance on Substances Prohibited in Animal Feed

11/26/2008

Federal Register Notice: FDA is making available, Draft Guidance for Industry: Small Entities Compliance Guide for Renderers &mdas...

Info on Med Guide Requirements Sent to OMB

11/26/2008

Federal Register Notice: FDA’s proposed collection of information, Prescription Drug Product Labeling: Medication Guide Requ...

Comments Sought on TV Drug Ad Toll-Free Numbers

11/26/2008

Federal Register Notice: FDA is seeking comments on a study examining the impact on consumer comprehension of inclusion of a toll-...

Workshop on Sex Differences in Cardio Device Trials

11/26/2008

Federal Register Notice: FDA and AdvaMed are co-sponsoring a public workshop 12/9, “Sex Differences in the Cardiovascular De...

Panel to Discuss Erbitux and Vectibix Oncology Drugs

11/21/2008

Federal Register Notice: FDA’s Oncologic Drugs Advisory Committee will meet 12/16, from 8 a.m. to 4 p.m. at the Hilton Washi...

Nubain Not Withdrawn for S&E

11/21/2008

Federal Register Notice: FDA has determined that Nubain (nalbuphine hydrochloride) injection, 10 and 20 mg/ml, was not withdrawn f...

Comments Sought on Single-Use Device Labeling

11/17/2008

Federal Register Notice: FDA seeks comments on reprocessed single-use device labeling, “Compliance With Section 301 of the M...

Somatuline Depot Review Period Set

11/17/2008

Federal Register Notice: FDA has determined the regulatory review period for Somatuline Depot is 3,629 days for extending a patent...