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BIO Supports Budget Action to Free up FDA User Fees

2013-12-13 06:00:00| Industrial Newsroom - All News for Today

BIO applauded House of Representatives for passing bipartisan budget deal that raises discretionary budget caps, which should provide FDA with complete access to its user fees for fiscal years 2014 and 2015. Thus commending Congress, BIO President and CEO Jim Greenwood noted "the forward-thinking action" and called on House and Senate to pass both S. 1413, Pryor/Blunt FDA User Fee Protection Act, and H.R. 2725, Lance/Eshoo FDA SOS Act, to ensure FDA user fees are never again sequestered. This story is related to the following:Trade Associations

Tags: free user action budget

 

Merck Statement on FDA Advisory Committee for GRASTEK (Timothy Grass Pollen Allergen Extract), Mercks Investigational Sublingual Allergy Immunotherapy Tablet

2013-12-13 01:17:00| Merck.com - Product News

Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today issued the following statement after the conclusion of the Allergenic Products Advisory Committee of the U.S. Food and Drug Administration (FDA) meeting to discuss GRASTEK (Timothy grass pollen allergen extract). Language: English Contact: MerckMedia:Pamela Eisele, 908-423-5042orRobert Consalvo, 908-423-6595orInvestors:Carol Ferguson, 908-423-4465orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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FDA panel says Merck's allergy drug effective

2013-12-13 00:03:44| Biotech - Topix.net

A panel of experts advising the U.S. Food and Drug Administration said an oral drug made by Merck & Co was effective in treating grass pollen allergy but expressed concerns about the drug's safety in children.

Tags: effective panel drug allergy

 

New FDA guidelines on reducing antibiotic misuse in livestock industry is a bunch of bologna

2013-12-12 19:00:58| Livestock - Topix.net

The U.S. Food and Drug Administration has finally issued its long awaited guidelines to reduce misuse of antibiotics in livestock production.

Tags: of industry guidelines reducing

 

Orexigen Therapeutics resubmits Contrave to FDA

2013-12-12 11:39:48| Biotech - Topix.net

The FDA refused to approve Contrave in 2011, citing concerns over cardiovascular risk.

Tags: fda therapeutics

 

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