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In trials for high-risk women, the FDA recommends only superiority designs because the historical evidence of prevention efficacy in at-risk women makes determining a non-inferiority margin difficult to impossible. Read More
A 2014 court ruling found that any drug is entitled to an exclusivity period if it has been designated as an orphan drug for a qualifying condition or disease and also approved for marketing. Read More
The most recent Congressional budget deal holds drug corporations responsible for 70 percent of prescription drug costs in the donut hole beginning next year, a 20 percent increase. Read More
In a second successful legal challenge of the FDA’s approach to orphan drug designations, a federal court ordered the agency to grant Eagle Pharmaceuticals orphan drug exclusivity for its cancer drug Bendeka. Read More
Clinical trials for HIV prevention drugs should generally involve two well-controlled trials, but a single Phase III trial can suffice if the results are supported by additional evidence, the FDA said in a new draft guidance. Read More
The FDA released a list of alternative suggestions for complying with CGMP requirements for drug combination products that covers stability testing, release for distribution, reserve samples and special testing requirements. Read More
Mandated under the 21st Century Cures Act, the guidance is meant to facilitate the advancement and use of systematic approaches to collect meaningful patient and caregiver data that can better inform medical product development. Read More
The complaint accuses the defendants of distributing and sponsoring unbranded promotional materials that misrepresented the risks of addiction, overdose and death associated with their products. Read More
Massachusetts opened a new front in litigation against opioid manufacturers as Attorney General Maura Healey filed a lawsuit Tuesday accusing Purdue and 16 current and former executives and directors of contributing to the opioid crisis and to the deaths of nearly 700 Massachusetts residents since 2009. Read More