Ethics/Regulatory

Concerns grow over CMS missing Sunshine Act draft deadline as data collection start date looms

Monday, October 17, 2011 08:02 AM

Industry groups have expressed concern about the Centers for Medicare and Medicaid Services (CMS) missing its deadline for drafting regulations to implement the so-called sunshine law, which requires sponsors to publicly disclose payments to physicians and teaching hospitals. Pharmaceutical and biotechnology companies must begin collecting data to comply with the law in less than 11 weeks.

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Pearl IRB expands into compliance and consulting

Monday, October 17, 2011 08:00 AM

Indianapolis-based Pearl IRB is expanding. The commercial institutional review board, launched just last year, is now adding a regulatory and compliance division, as well as a consulting division that will focus on helping life sciences startups.

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ACRO endorses Foreign Earnings Reinvestment Act

Wednesday, October 12, 2011 10:10 AM

The Association of Clinical Research Organizations (ACRO) supports the Foreign Earnings Reinvestment Act, bipartisan legislation introduced in the U.S. Senate last week by senators Kay Hagan (D-NC) and John McCain (R-AZ).

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FDA commissioner outlines steps to spur biomedical innovation

Thursday, October 6, 2011 12:18 PM

FDA Commissioner Margaret A. Hamburg, M.D., has released a blueprint containing immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans.

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Academia and industry seek revisions to Clinical Trials Directive

Wednesday, September 28, 2011 12:20 PM

The European Union’s Clinical Trials Directive has resulted in unnecessary complexity and bureaucracy that are hampering the progress of medical research by pushing up the time and costs needed to get clinical studies underway, academic and industry stakeholders from the UK and Europe contend, according to PharmaTimes.

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Survey debunks consumer belief that all new FDA-approved drugs are better than the old

Monday, September 26, 2011 08:00 AM

Many consumers believe drugs do not receive FDA approval unless they are extremely effective and don’t have major side effects. At the same time, it’s a commonly held belief that new drugs are always safer than drugs that have been on the market for many years.

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Obama seeks $135 billion in drug discounts over 10 years

Friday, September 23, 2011 10:55 AM

The US Obama Administration has outlined plans to make $320 billion healthcare savings over a decade, including requiring drug makers to provide $135 billion worth of discounts on medicines supplied under the Medicare prescription drug benefit, according to PharmaTimes.

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EU Clinical Trials Register to be available on WHO’s ICTRP portal

Thursday, September 22, 2011 02:13 PM

The European Union Clinical Trials Register (EU-CTR) has been recognized as one of the primary registries for the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP), according to PharmaTimes.

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Obama plans to reduce market exclusivity to 7 years

Tuesday, September 20, 2011 02:03 PM

President Obama is not giving up when it comes to trying to introduce competition to expensive drugs made by biotechnology, according to a report by the New York Times.

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EMA joins FDA in growing movement toward risk-based monitoring of clinical trials

Monday, September 19, 2011 08:02 AM

Along with the FDA and the Clinical Trials Transformation Initiative (CTTI), the European Medicines Agency (EMA) is advocating for risk-based monitoring of trials, while at the same time saying current GCP rules render quality management in trials too costly and need to be reworked.

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