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FDA to Consider Vaccine Trial Cooperative Agreement

05/16/2012

Federal Register Notice: FDA announces its intention to accept and consider a single source application for an award of a cooperat...

OTC Sunscreen Compliance Dates Delayed

05/11/2012

Federal Register Final rule: FDA is delaying the compliance dates for the 6/17/11 final rule for OTC sunscreen drug products that ...

Review Period Set for Asthmatx’ Bronchial System

05/02/2012

Federal Register Notice: FDA has determined the regulatory review period for Asthmatx, Inc.’s Alair Bronchial Thermoplasty S...

Review Period Set for Novo Nordisk’s Victoza

05/02/2012

Federal Register Notice: FDA has determined the regulatory review period for Novo Nordisk’s Victoza is 3,370 days for extend...

Review Period Set for Kalbitor

05/02/2012

Federal Register Notice: FDA has determined the regulatory review period for Dyax Corp.’s Kalbitor (ecallantide) is 2,855 da...

FDA Expands Clinical Investigator Disqualification Regs

04/30/2012

Federal Register Final rule: FDA is amending the regulations to expand the scope of clinical investigator disqualification. When t...

Panel to Discuss Janssen’s Xarelto

04/12/2012

Federal Register Notice: FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet 5/23 2012, from 8 a.m. to 5 p.m. ...

Nominations Sought for Blood Products Panel

04/12/2012

Federal Register Notice: FDA is requesting that any industry organizations interested in participating in the selection of a nonvo...

Comments Sought on Detained/Banned Devices

04/10/2012

Federal Register Notice: FDA is seeking comments on information collection for administrative detention and banned medical devices...

OMB OKs Info on FDA Recall Regs

04/10/2012

Federal Register Notice: FDA’s collection of information entitled “Food and Drug Administration Recall Regulations,&rd...