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The Senate’s bill to reauthorize FDA user fee programs for drugs, biologics and medical devices, introduced last week by Sen. Patty Murray (D-Wash.) and Sen. Richard Burr (N.C.), includes proposed reforms of the FDA’s accelerated approval program, a subject the House declined to address in its version of the user fee program reauthorization. Read More
A bipartisan pair of senators — Maggie Hassan (D-N.H.) and Bill Cassidy (R-La.) — are pressing federal agencies to close oversight gaps that delay generic drugs and in turn keep drug prices high. Read More
Zealand Pharma will bring a new form of its antihypoglycemia drug Zealogue (dasiglucagon) to the FDA as a potential treatment for children with congenital hyperinsulinism (CHI). Read More
The Department of Health and Human Services (HHS) has withdrawn a controversial and unpopular Trump-era final rule that would have required federal health agencies to reassess their regulations every 10 years or face eliminating those rules. Read More
Teva Pharmaceuticals and Allergan will pay more than $161 million to the state of West Virginia to settle allegations that the companies contributed to the opioid epidemic. Read More
Sens. Maria Cantwell (D-Wash.) and Chuck Grassley (R-Iowa) introduced a bill this week that directs the Federal Trade Commission (FTC) to hold pharmacy benefit managers (PBM) accountable for allegedly deceptive pricing practices that raise the costs of prescription drugs. Read More
The FDA issued skincare drug product developer Clinical Formula a five-observation Form 483 for lacking an effective quality control unit and other serious deficiencies observed during a November-December 2021 inspection of its Newport Beach, Calif., facility. Read More
In an effort to get more gonadotropin-releasing hormone (GnRH) analogues to market for advanced prostate cancer patients, the FDA has published final guidance with recommendations spanning the full spectrum of development, including clinical trial design. Read More