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Comments Sought on User Fee Cover Sheet

06/08/2009

Federal Register Notice: FDA is seeking public comment on Form FDA 3397, User Fee Cover Sheet, that must be submitted along with c...

Panel to Discuss King’s NDA to Detect Perfusion Abnormalities

06/08/2009

Federal Register Notice: FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet 7/28 from 8 a.m. to 5 p.m. at the...

Animal Drug Sponsor Changed to Paladin Labs

06/05/2009

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

Guidance on Risk Info in Promos

05/27/2009

Federal Register Notice: FDA is making available a draft guidance for industry, Presenting Risk Information in Prescription Drug a...

Animal Drug Sponsor Changed to Virbac

05/27/2009

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

Ortho Wants Doxil Bioequivalence Requirements

05/18/2009

Ortho-Biotech has asked FDA to adopt bioequivalence requirements including clinical trials to govern approval of any ANDA or 505(b...

FDA Balks at More Transparency in Rulemaking

05/11/2009

Long under external attack for a lack of public transparency in its operations, FDA is now balking at a recommendation that it imp...

Synthes Settles NJ Conflict-of-Interest Suit

05/07/2009

Medical device maker Synthes has signed a settlement agreement with New Jersey attorney general Anne Milgram to resolve allegation...

Two Preemption Cases Back to District Courts

05/05/2009

The Third Circuit Court of Appeals has sent two drug preemption cases back to district courts for further proceedings in light of ...

Attorney Says FDA May be More Dangerous Than Flu

05/05/2009

Attorney John Whitehead¸ founder and president of the Rutherford Institute, says FDA’s close relationship with drug co...