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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In a draft guidance issued today, the FDA lists three reasons the agency might rescind a Breakthrough Therapy designation (BTD), citing a change in the data supporting the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
On Thursday, the House Committee on Appropriations voted 31 to 26 to adopt a bill that would increase the FDA’s nonuser fee funding by 10 percent in 2023. Read More
“By incentivizing coordination, we can empower patent examiners and in turn boost competition, including for prescription drugs,” Sen. Durbin said. Read More
The Center for Biologics Evaluation and Research yesterday released an updated guidance agenda for 2022 that includes the following planned guidances on tissues and advanced therapies in addition to those already released this year: Read More
Glicerinas Industriales (Glinsa) has received a warning letter from the FDA after refusing to let the agency inspect its facility in Jalisco, Mexico. Read More
Enanta Pharmaceuticals is accusing Pfizer of patent infringement, claiming Paxlovid (nirmatrelvir tablets; ritonavir tablets) is in violation of Encanta’s patent for its under-development antiviral COVID pill. Read More
The buzz at the Drug Information Association’s (DIA) annual meeting — being held in person this week in Chicago after two “virtual” years — is focused largely on user fee reauthorization as a legislative package makes its way through the Senate following the passage of a House version on June 8. Read More