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Biopharmaceutical and Medical Device Associations Strongly Support Senate Bill to Exempt FDA ...

2013-08-01 06:00:00| Industrial Newsroom - All News for Today

Senators Mark Pryor (D-AR), Roy Blunt (R-MO), Daniel Coats (R-IN), Al Franken (D-MN), and Jerry Moran (R-KS) introduced S. 1413 to exempt future FDA user fees from sequestration. AdvaMed, BIO, GPhA, MITA, and PhRMA, representing biopharmaceutical and medical device companies, praised efforts to prevent sequestration of future FDA user fees. They also urged Congress to find bipartisan solution for releasing sequestered FY13 user fees as Congress continues work on FY14 appropriations ...This story is related to the following:Trade Associations

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US FDA proposes new regulations to ensure safety of imported food

2013-07-30 01:00:00| Food Processing Technology

The US Food and Drug Administration (FDA) has proposed two new regulations which are aimed at helping to ensure that imported food complies with the same safety standards as food produced in the country.

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Mallinckrodt New Drug Application Granted Priority Review By FDA

2013-07-29 11:00:00| drugdiscoveryonline Home Page

Mallinckrodt recently announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for MNK-795 and granted priority review

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Vertex sinks after FDA freezes portion of hepatitis drug trial

2013-07-26 19:57:48| Biotech - Topix.net

Investors pounded Vertex Pharmaceuticals in after-hours trading Thursday after the company announced that the U.S. Food and Drug Administration had placed a partial hold on a drug trial for a hepatitis C therapy that may have contributed to liver toxicity in some patients.

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FDA Announces Two Proposed Rules Towards FSMA Implementation

2013-07-26 10:00:00| Expeditors Newsflash - Americas Edition

Expeditors Newsflash - Americas Edition

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