Ethics/Regulatory

Watchdog group files amendment to FDA Citizen Petition

Wednesday, March 30, 2016

With deaths in clinical drug trials every month since December 2015, Center for Responsible Science (CRS) has updated its July 2015 citizen petition. The petition urges the FDA to update 29 regulations to allow the preclinical test method most predictive of human response is used during drug testing. Current regulations mandate the use of animal models, despite great progress in more human relevant tests.

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FDA releases enhanced warnings for immediate-release opioid pain medications

Wednesday, March 23, 2016

In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the FDA has announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. These actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

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EMA launches PRIME for unmet medical need medicines

Monday, March 7, 2016

The EMA has launched its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need. The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. These medicines are considered priority medicines within the European Union (EU).

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WIRB-Copernicus develops ethics tool kit for clinical research protocols

Wednesday, March 2, 2016

WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services and software to support clinical research, has announced the publication of an innovative Ethics Tool Kit in the Journal of Medical Ethics. Developed by the Multi-Regional Clinical Trials (MRCT) Center of Harvard and Brigham and Women’s Hospital working group, the toolkit was co-written by 20 experts in clinical research, including WCG Chief Medical Officer and President of Consulting Services Lindsay McNair, M.D., MPH, MSB, and WCG Chief Compliance Officer David Forster, JD, MA, CIP.

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PhRMA sues to block Ohio drug pricing initiative from Nov. 2016 ballot

Tuesday, March 1, 2016

Backers of an Ohio ballot initiative addressing inflated drug prices have criticized the Pharmaceutical Researchers and Manufacturers of America (PhRMA), a drug industry trade group, for filing a lawsuit to block the ballot initiative from even appearing on the November 2016 ballot. The lawsuit was filed in the Supreme Court of Ohio (Case # 2016-313) challenging The Ohio Drug Price Relief Act, a citizen-driven ballot initiative that will revise Ohio law to require state programs pay no more than the U.S. Department of Veterans Affairs for prescription medications. V.A. pricing is generally believed to be 20% to 24% lower than for almost any other government program.

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