300 Employees Impacted as Teva to Shut Down or Sell Virginia Plant
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-teva.jpg" NAME"300 Employees Impacted as Teva to Shut Down or Sell Virginia Plant" ALT"300 Employees Impacted as Teva to Shut Down or Sell Virginia Plant"March 16, 2017By Mark Terry,…
True or False: Publishing Negative Results Ruins Your Science Career
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x430-publishing-negative-results-ruins-your-science-career.jpg" NAME"Attention Bay Area: Chan-Zuckerberg's BIOHUB is Hiring Lots of ScientistsTrue or False: Publishing Negative Results Ruins Your Science Career" ALT"True or False: Publishing Negative Results Ruins Your Science…
FDA Warns Supplement Maker for Misbranding, Lack of Written Procedures
Dietary supplement firm Cape Fear Naturals landed a warning letter from the FDA over misbranding of products and GMP issues. Source: Drug Industry Daily
ABPI Rebukes Four Drugmakers for Breaching Code of Practice
The Association of the British Pharmaceutical Industry found four drugmakers — Celgene, Takeda, Vifor Pharma and Pierre Fabre — violated the group’s code of practice by engaging in activities ranging…
House E&C Committee Leaders Seek Additional Info on FDA’s Heparin Investigations
Republican leaders from the House Energy and Commerce Committee have asked the FDA to provide all documents related to the agency’s criminal investigations into the heparin contamination crisis. Source: Drug Industry…
FDA Committee Suggests Flexible Approach to Qualifying Data
The FDA should allow developers of new and generic drugs more flexibility when they submit model-informed data, an advisory committee said. Source: Drug Industry Daily
FTC: Shire ViroPharma Filed Baseless Claims to Block Generics
A complaint from the Federal Trade Commission alleges Shire ViroPharma unlawfully stifled generic competition. Source: Generic Line
GAO Downgrades Rating of FDA’s Action Plans for Postmarket Monitoring
In its latest biennial report to Congress on high-risk government programs, the GAO downgraded its rating of the FDA’s action plans, saying CDER, CBER and CDRH’s long-term strategies lack adequate…
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