We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Novo Nordisk achieved settlements that force two clinics to cease selling unapproved versions of the company’s semaglutide products and explain in their marketing materials that unapproved compounded drugs have not been evaluated or approved by the FDA. Read More
While consumers wanting the ability to fix products they’ve purchased came through with over 1,600 comments and strongly-worded frustrations supporting their “right to repair” their own possessions, the issue continues to rankle medical device makers looking to protect their intellectual property rights and the safety of FDA-regulated medical devices. Read More
Over the past week, the FDA issued final guidance on reporting drugs and biologicals under Section510(j)(3) of the FD&C Act. Draft guidance was issued on notifications of a discontinuance or interruption in manufacturing under Section 506C of the FD&C Act. The agency also announced meetings of the Oncologic Drugs Advisory Committee and the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. Read More
Petitioners seeking the use of “march-in” rights to obtain lower pricing on Astellas’s prostate cancer drug Xtandi (enzalutamide) may not have been successful in their appeal, but did obtain HHS recognition of the need to evaluate pricing in the use of march-in rights. Read More
Consistent open communication and complete public transparency is the only way to counteract scientific misinformation, which is a considerable threat to public health today, said Kimberlee Trzeciak, deputy chairman of FDA’s Office ofPolicy, Legislation, and International Affairs. Read More
When questioned by senators in a hearing Thursday about why Americans pay exponentially more for many brand name drugs than residents of other countries, pharmaceutical company CEOs repeatedly pointed to rebates they must offer to pharmacy benefit managers (PBM) as the real problem, an allegation the committee soundly rejected. Read More
The FDA has issued a draft guidance on how and when applicants and manufacturers should provide information on interruptions or discontinuations of drugs, biological products and active pharmaceutical ingredients to help the agency prevent or mitigate shortages. Read More
This edition of interesting device approvals and clearances includes a pulsed field ablation system, a transesophageal echocardiography ultrasound transducer, a digital cytology system that combines deep-learning-based AI, and a deep brain stimulation system. Read More
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has proposed waiving certain requirements for biosimilars on “solid” evidence of quality comparability. Read More
Vanda Pharmaceuticals is once again suing HHS and the FDA, claiming that the agencies are using regulatory process to accomplish an “end run” around the timetable required by law in its efforts to obtain an approval or a hearing for a new indication for its drug Hetlioz (tasimelteon) as a treatment for insomnia. Read More
The FDA’s Office of Clinical Pharmacology (OCP) conducted more than 5,600 reviews of investigational new drug (IND) submissions in 2023, helping determine correct dosing for 55 new drugs and biological products. Read More
The Federal Trade Commission (FTC) has waded into the march-in rights fracas, supporting the obscure Bayh-Dole Act as a tool to moderate drug pricing and control patent thickets on drugs developed with federal funding. Read More