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An analysis of 10 FDA approved drug-device combinations containing GLP-1 receptor agonists found that the patents for the device portion made no mention of active drug ingredients — a requirement of FDA Orange Book listing. Read More
The FDA has finalized its 2021 draft version of a guidance that describes the timing and process of annual reporting of manufactured drugs, an effort intended to enhance the FDA’s visibility into drug supply chains. Read More
By overriding the FDA’s scientific judgments and methodology, the Fifth Circuit second-guessed the FDA’s Congressional mandate to consider all scientific evidence in drug approval decisions, the American Bar Association (ABA) wrote in its recent amicus brief on the Supreme Court’s upcoming review of the abortion drug mifepristone. Read More
A bipartisan group of six senators have released proposed reforms to the beleaguered 340B drug discount program that they claim will ensure the program fulfills its original purpose of supporting covered entities helping underserved populations. Read More
The Biden administration has sent initial offers to manufacturers of the first 10 drugs selected for drug price negotiation, saying this is the first time Medicare is not accepting the drug prices pharmaceutical companies set. Read More
Allowing courts to overturn science-driven drug approval decisions would open the door to a myriad of partisan legal challenges, exert a chilling effect on the business of drug development, and endanger patients, according to an amicus brief on the Fifth Circuit’s mifepristone restriction decision, filed by seven former FDA commissioners and acting commissioners. Read More
The FDA has issued a revised version of its Biosimilar User Fee Amendment (BsUFA) Research Roadmap and a list of guidances CBER plans to issue during 2024, both intended to clarify the agency’s priorities for 2024. Read More
Establishing the magnitude of the Philips Respironics recall, the FDA has announced that since April 2021, the agency has received more than 116,000 medical device reports (MDR), including 561 reports of deaths, associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam used in the company’s ventilators, BiPAP machines, and CPAP machines. Read More
The FDA will have to exponentially ramp up its hiring to properly understand and regulate quickly developing AI and the many ways it’s poised to change development of drugs and devices, said FDA Commissioner Robert Califf. Read More