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Gilead Sciences has reached a $33 million settlement with a Florida clinic accused of fraudulently applying to the company’s patient assistance program via homeless people and those in low-wage jobs in order to get access to Gilead’s pricey human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) drugs for free, then selling them on the black market. Read More
For circumstances when drugmakers feel labeling alone isn’t enough to ensure safe selection and use, the FDA is proposing a rule that would expand the pool of nonprescription drugs with “self-selection systems” that would identify the appropriate patients and guide them in taking the medicines safely. Read More
The FDA has released its Spring 2022 regulatory agenda, pushing back the timing of several previously announced proposed and final rules, and signaling its intention to issue a proposed rule on compounded drug products by the end of the year. Read More
The FDA should be allowed to reform the citizen petition process and change how complex generic drugs are approved, the Brookings Institution and the University of Southern California (USC) propose in a recently published paper. Read More
Under a new five-year action plan for accelerating the development of treatments for rare neurodegenerative diseases, the FDA will focus on incorporating new technologies and innovative trial approaches beginning with the study of amyotrophic lateral sclerosis (ALS). Read More
The FDA has expanded the scope of its 2013 drug manufacturing guidance on penicillin cross-contamination to cover compounds containing a non-penicillin beta-lactam ring, a chemical structure essential for antibacterial activity. Read More
A serious backlog of FDA inspections is causing problems for sponsors of biosimilars who are being especially affected by the delays, according to presenters at the Drug Information Association annual meeting in Chicago, June 19-23. Read More
The FDA claims it prevented a total of 317 drug shortages in 2021 — marking the highest number of potential shortages avoided since the agency began reporting them to Congress in 2012. Read More
Bipartisan legislation on lowering insulin costs is headed to a vote on the Senate floor “very soon,” according to U.S. Senate Majority Leader Chuck Schumer. Read More
In a draft guidance issued today, the FDA lists three reasons the agency might rescind a Breakthrough Therapy designation (BTD), citing a change in the data supporting the designation or the circumstances surrounding the drug’s development. Read More