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AAM recommends a drug stockpile and reserve capacity program and targeted federal grants for generic manufacturers with excess manufacturing capacity to reduce drug shortages. Read More
New FDA drug approvals in June include new gene therapies for ambulatory Duchenne Muscular Dystrophy and hemophilia A, a treatment for pediatric growth hormone deficiency and the first ever cell therapy for a severe form of type 1 diabetes. Additionally, the FDA approved a new device for skin repigmentation in patients with vitiligo. Read More
Use of real-world data (RWD) and real world evidence (RWE) continues to gain traction in countries around the world, as seen in a draft reflection paper endorsed by the International Council on Harmonisation and issued for comment by the European Medicines Authority (EMA). Read More
The FDA has updated how the Office of Pharmaceutical Quality (OPQ) will select manufacturing sites for routine surveillance inspection, using information about the compliance history of sites “to promote parity in inspectional coverage and the effective and efficient use of FDA resources to address the most significant public health risks.” Read More
The Association for Accessible Medicines (AAM) says that the “looming” Nov. 27 Drug Supply Chain Security Act deadline requiring interoperable exchange, verification and tracing for all drug products, could cause a spike in drug shortages. Read More
Amneal Pharmaceuticals’ recent complete response letter (CRL) for its investigational Parkinson’s extended-release drug IPX203 didn’t identify any issues with efficacy or manufacturing — just the safety of one of the two ingredients in the NDA. Read More
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the WCG MAGI Clinical Research Conference and webinars on the FDA’s sterilization pilot and design control. Read More
In the face of multiple lawsuits and 7,500 public comments, CMS adjusted some aspects of the Inflation Reduction Act’s drug price negotiation provisions, but the changes don’t lessen the law’s overall power to require pharmaceutical companies to sell medications to the government at what they fear will reflect below-market rates. Read More
The FTC’s lawsuit to block the merger of Amgen and Horizon violates the companies’ right to due process as, with the case relegated to an administrative law judge (ALJ) and not a jury, the commission will be “playing the roles of ‘investigator, prosecutor, and judge,’” the companies said in their June 29 counterclaim filing. Read More
Feedback on the FDA’s draft guidance for incorporating clinical outcome assessments (COA) into endpoints has trickled in from a number of stakeholders, including BIO and the International Society for Cell & Gene Therapy, who feel the guidance would be well served with expansion and clarification in certain areas. Read More