FDA

BioSante completes study enrollment

Tuesday, March 1, 2011 08:40 AM

BioSante Pharmaceuticals has completed enrollment of subjects in the first of two pivotal phase III LibiGel (testosterone gel) safety and efficacy trials, being conducted under an FDA-approved special protocol assessment (SPA) agreement.

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FDA issues complete response to Protalix

Tuesday, March 1, 2011 08:33 AM

The FDA has issued a complete response letter for Protalix's Gaucher's disease drug taliglucerase alfa. Protalix won't be required to conduct any additional clinical studies, but that didn't stop its stock from plunging on the news, FierceBiotech reported.

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NicOx to appeal FDA rejection

Tuesday, March 1, 2011 08:30 AM

French biotech NicOx said last week it plans to appeal the FDA’s decision to turn down its anti-inflammatory drug naproxcinod for marketing approval, Reuters reported. NicOx made the announcement at its 2010 earnings presentation.

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FDA issues warning letter to Sanofi-aventis

Tuesday, March 1, 2011 08:00 AM

The FDA has warned Sanofi-Aventis’ U.S. unit for failing to submit reports of possible serious drug side effects in a timely manner. In a Jan. 28 letter made public last week, the FDA said an early response from the drugmaker and its "promised corrective actions are inadequate to address the deficiencies."

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Caraco Pharma to merge with majority owner Sun

Tuesday, March 1, 2011 08:00 AM

Detroit-based Caraco Pharmaceutical Laboratorieshas agreed to merge with majority owner Sun Pharmaceutical Industries andSun Pharma Global, according to Crain’s Detroit Business.

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Technology companies adapt interactive video concepts for clinical trial informed consent

Monday, February 14, 2011 10:15 AM

Interactive videos, complete with soothing voices, explain hospital surgeries step-by-step, along with the risks and benefits, to enable patients to make informed decisions. Now, producers of these videos are adapting them for the clinical trials space, which for decades has relied on paper documents that often fail to adequately inform prospective volunteers.

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The CenterWatch Monthly February 2011

Thursday, February 3, 2011 01:08 PM

The High Cost and Questionable Impact of 100% SDV 

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FDA issues 19 action items to improve transparency

Tuesday, January 18, 2011 12:22 PM

As part of its ongoing transparency initiative, the U.S. Food and Drug Administration has issued 19 action items including a new website to help the industry save time and resources in its interaction with the agency.

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Maryland woos away top deputy at the FDA

Wednesday, January 5, 2011 12:21 PM

Joshua M. Sharfstein, the second-in-command at the Food and Drug Administration, is leaving that post after less than two years to become Maryland's top public health official, Gov. Martin O'Malley said Tuesday and as reported by The Washington Post.

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Survey: relationship between FDA and life sciences industry deteriorating, delays in review process cited

Monday, December 13, 2010 07:00 AM

Top biopharmaceutical company executives are frustrated with delays and inconsistencies in the Food and Drug Administration (FDA) regulatory review process and are concerned that passage of the healthcare reform law, which gave the already resource-constrained agency more responsibilities, will further complicate drug approvals, according to a new PricewaterhouseCoopers (PwC) survey.

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