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The recruitment and retention of Bioresearch Monitoring (BIMO) program investigators has been a thorn in the side of the FDA that’s negatively impacted trial inspections, a Government Accountability Office (GAO) audit has found. Read More
Closing on May 31, the European Medicines Agency (EMA) has opened a second consultation for its guideline on requirements for investigational advanced therapy medicinal products (ATMP) in clinical trials. Read More
The FDA on Monday announced creation of the new Quantitative Medicine (QM) Center of Excellence to facilitate and coordinate the continuous evolution and consistent application of QM across CDER. 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
This edition of Quick Notes looks at the first nonsteroidal oral med for Duchenne muscular dystrophy, expanded indications for a cardiovascular risk reduction drug, an oncology approval, two Complete Response Letters for trial enrollment, and a combo pill for pulmonary hypertension. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. 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
An FDA advisory committee on Thursday gave its unanimous blessing to Balance Opthalmics’ FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) system as a nightly use adjunct therapy for reducing intraocular pressure in adults with open-angle glaucoma and intraocular pressure 21 mmHg or less. Read More
The FDA has identified product recalls for Vyaire’s AirLife Manual Resuscitators and for the use instructions for Abiomed’s left-sided heart pumps as Class I, while device manufacturer InfuTronix is voluntarily recalling its line of Nimbus Infusion Pumps after design flaws prompted thousands of customer complaints. Read More
Over the past week, the FDA published a draft rule on drug products that present demonstrable difficulties for compounding. Final guidance was issued on controlled correspondence for generic drug development. Draft guidance on real-world evidence in drug and biological products’ non-interventional studies was also issued. Read More
This edition of Quick Notes reviews four CHMP positive opinions, including a once-weekly insulin treatment for patients with type 2 diabetes, an oral monotherapy for patients with a rare blood disease, a new antibiotic to treat multi-drug resistant bacteria, and a generic multiple sclerosis drug treatment. Read More