Podcast: Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
On February 22, 2024, Artiva announced that the FDA has granted Fast Track designation to Artiva’s AlloNK (AB-101) for the treatment of lupus nephritis in combination with rituximab or obinutuzumab. ...more
Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. Designed to overcome the unique challenges posed by military medical...more
Federal regulators have hit a highly public reckoning for their policies to provide speedy approvals for prescription drugs, benefiting Big Pharma’s profits but not necessarily patients — notably women in serious need of help...more
BridgeBio’s recently announced sale of an FDA Priority Review Voucher for $110 million reflects a robust secondary market for these regulatory fast passes. Prices for Priority Review Voucher (“PRVs”) reflect the high stakes...more
The Food and Drug Administration recently approved a drug product to treat Alzheimer’s disease under the accelerated approval pathway, putting the spotlight back on what exactly is “accelerated approval?” This Bulletin will...more
On February 3, 2020, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement announcing their plans to collaborate in promoting competitive biological product markets and...more
For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now: “Some of them are really great,”...more
On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement Public Law...more
Yesterday, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development, review, and Emergency Use Authorization (EUA) for medical products...more
Last week, Dr. Scott Gottlieb, Commissioner of the FDA, touched on two issues that have frequented headlines in the past two years. First, in remarks made on November 28, 2017, Commissioner Gottlieb expanded on plans to...more
The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more