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A new draft guidance issued by the FDA Friday provides recommendations for using animal studies to assess the in vivo performance of dental bone grafting materials. Read More
This edition of Quick Notes reviews Merck’s pulmonary arterial hypertension treatment with Winrevair, a fourth approval for AstraZeneca’s Ultomiris, Akebia approval for Vafseo tablets and another clearance for Neuronetics’ Neurostar device. Read More
The FDA and U.S. Customs and Border Protection (CBP) are partnering to promote supply chain traceability and improve the government’s visibility into imports by focusing on Global Business Identifiers (GBI), unique numbers that capture information about legal business entities and their functions within the supply chain. Read More
Comments are sought by the Scientific Committee on Health, Environmental and Emerging Risks on an update of the European Commission guidelines on the presence of phthalates in medical devices. Read More
In a step rarely taken by the agency, the FDA today has proposed a ban of electrical stimulation devices (ESD) intended to reduce or stop self-injurious or aggressive behavior because the agency has determined that these devices present an unreasonable and substantial risk of illness or injury. Read More
A week following the EPA’s announced new rules for facilities emitting cancer-causing ethylene oxide (EtO), FDA officials urged consensus standards be developed and broadly accepted for medical device sterilization protocols and premarket submissions. Read More
The FTC has filed an amicus brief in a suit between Teva Pharmaceuticals and Amneal Pharmaceuticals, supporting Amneal and saying Teva has improperly listed the patents in dispute in the FDA’s Orange Book, and urged the court to order Teva’s listings removed. Read More
All but one of the five experts testifying at the hearing agreed that the field of LDTs would be irreparably harmed by the FDA’s proposed rule. Read More