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Tag: fda
CBP Announces New FDA Pilot through ACE
2015-08-26 10:00:00| Expeditors Newsflash - Americas Edition
Expeditors Newsflash - Americas Edition
AFIA feels the FDA crosses line with proposal for monitoring antibiotics in ag
2015-08-21 21:38:00| National Hog Farmer
Source: American Feed Industry Association The American Feed Industry Associations legal counsel earlier this week submitted comments on behalf of the organization to the U.S. Food and Drug Administration on the proposed rule making on antimicrobial animal drug sales and distribution reporting. read more
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monitoring
proposal
FDA releases biannual antimicrobial progress report
2015-08-21 21:29:00| National Hog Farmer
Source: U.S. Food and Drug Administration The U.S. Food and Drug Administration announced Aug. 21 its third progress report highlighting its recent actions to promote the judicious use of antimicrobials in food-producing animals, public meeting also announced. read more
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progress
releases
fda
FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks Anti-PD-1 Therapy, for First-Line Treatment of Advanced Melanoma, and Grants Priority Review
2015-08-18 14:00:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Merck Provides Additional Update: FDA Extends Action Date for Additional sBLA in Ipilimumab-Refractory Advanced Melanoma KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks anti-PD-1 therapy. Merck is seeking approval for KEYTRUDA, at the currently approved dose of 2 mg/kg every three weeks, for the first-line treatment of unresectable or metastatic melanoma patients. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orInvestors:Justin Holko, 908-740-1879An Phan, 908-255-6325 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: advanced
review
application
license
FDA Quality Metrics Draft Guidance: What You Need to Know to be Prepared for Implementation
2015-08-10 12:42:59| drugdiscoveryonline Home Page
Date: Thursday, September 17, 2015 Time:1pm - 2:30pm EDT Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts!
Tags: to
quality
prepared
implementation
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