Ethics/Regulatory

FDA approves Whooping Cough vaccine

Monday, July 11, 2011 12:24 PM

The FDA has approved GlaxoSmithKline’s BOOSTRIXR [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed (Tdap)] for use in adults 65 years of age and older for active booster immunization against tetanus, diphtheria and pertussis (whooping cough). This approval makes BOOSTRIX the first Tdap vaccine approved for use in this age group.

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Study brokers Interspond, Elias Research head to court over alleged trade secret violations

Monday, July 11, 2011 08:02 AM

Two trial management firms (TMOs), known more commonly in the industry as study brokers, have taken their disagreement to court.

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Examination of cancer drug approvals shows FDA is faster than EMA, disproving an ‘urban myth’

Monday, July 11, 2011 08:00 AM

It has been a long-held belief that European regulators are willing to take more innovative approaches to ushering drugs through the regulatory process. And several recent reports have criticized the FDA for being inefficient in its approval process for medical devices compared to the European Medicines Agency (EMA). Complaints about cancer drugs being held up in the U.S. regulatory process are particularly widespread.

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FDA says drug approvals highest in two decades

Friday, July 8, 2011 02:15 PM

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, testified before the U.S. House Energy and Commerce's health subcommittee that first-cycle drug approvals are at a 20-year high, and more than two-thirds of new treatments are being cleared within the time frames given to new drug applications.

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Harvard disciplines three psychiatrists under Sunshine Act

Wednesday, July 6, 2011 09:59 AM

Harvard Medical School and Massachusetts General Hospital have disciplined three faculty members in a conflict-of-interest case that became a prime exhibit in the debate over the federal Physician Payments Sunshine Act of 2010, according to the NPR Health Blog.

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Study raises concerns about orphan drug safety, citing fewer patients, lower standards in clinical trials

Tuesday, July 5, 2011 08:00 AM

Pivotal trials for orphan cancer drugs often have fewer patients and lower standards than trials for more prevalent cancers, raising concerns about the safety and efficacy of some drugs approved to treat rare medical conditions, according to a new study published in the Journal of the American Medical Association (JAMA).

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Study: Canadians regulators delaying drug approvals up to 30 months

Thursday, June 30, 2011 01:17 PM

Canada's federal and provincial governments are now taking more than two and a half years, on average, to approve new prescription medicines, according to a new study from free-market think tank The Fraser Institute and reported by PharmaTimes.

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Two researches charged with falsifying clinical data

Friday, June 3, 2011 01:52 PM

Two former employees of Kansas-based Lee Research Institute have been indicted for falsifying study data in a clinical trial, according to a report in the Kansas City Business Journal.

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FDA to post inspection information online

Thursday, June 2, 2011 01:46 PM

The FDA will publish more details about inspections and court actions on its web site as part of a drive toward transparency, according to a report on InPharm.

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U.S. R&D productivity often undercounted, as most reports omit FDA biologics approvals

Tuesday, May 31, 2011 09:44 AM

Most reports of pharmaceutical R&D productivity undercount the number of new drugs that reach the market each year, missing out on billions of dollars of sales, because they omit approvals from the Food and Drug Administration’s (FDA) biologics division, according to a new report by London-based research company EvaluatePharma.

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