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The FDA hit back at Teva’s lawsuit accusing the agency of changing its policy on granting 180-day exclusivity for generics — arguing that the company’s attempt to block exclusivity for competing Restasis (cyclosporine) generics was “built atop a tottering tower of conjecture.” Read More
FDA Commissioner Scott Gottlieb said the agency is committed to ensuring “timely completion” of post-marketing studies by drug sponsors in a statement about the agency’s latest report on the status of reviews. Read More
The FDA is seeking public comment on how it should regulate prescription drug software apps and says some apps might have to be regulated as a device — such as a software program that uses advanced algorithms to scan skin lesions for evidence of cancer. Read More
Commissioner Scott Gottlieb unveiled a redesigned FDA website on expanded access to clinical trials on Nov. 8 and said the agency is “deeply committed” to helping critically ill patients with no other treatment options to join trials. Read More
International regulators need to take action to reverse the steep decline in research and development for antibiotics, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Read More
Some nations may be consuming too many antibiotics that the World Health Organization has determined must be reserved for emergencies to limit antibiotic resistance. Read More
The European Medicines Agency issued an updated action plan to encourage advanced therapy medicinal products (ATMPs) — including the release by year’s end of draft guidelines for clinical trial sponsors. Read More
The European Medicines Agency’s updated guidelines on good pharmacovigilance practices took effect Nov. 8 — urging sponsors to pay particular attention to symptoms subjects may be unable to communicate. Read More
The Trump administration’s newly negotiated trade deal with Canada and Mexico threatens to keep American drug prices high, two dozen-plus consumer, health, trade and other organizations warned in a letter to the U.S. Trade Representative. The 29 groups — including the Association for Accessible Medicines (AAM) and the AARP — claim some provisions in the proposed NAFTA overhaul are inconsistent with U.S. law. Read More