The FDA’s CDER has released 2023 Annual Reports for its Offices of New Drugs (OND) and Translational Services (OTS), highlighting activities that span dozens of drug approvals and guidances from…

In this edition of Quick Notes are drug approvals to treat hemophilia B, rare genetic disorder WHIM, cervical cancer, cluster seizures in children with epilepsy and a new formulation of…

This week, the FDA announced a Metabolic Drugs Advisory Committee meeting and a listening session on advisory committees. Draft guidances were published on content and format of NDA and ANDA…

Using Sarepta’s treatment for Duchenne muscular dystrophy (DMD) as an example, a researcher from the Institute for Clinical Review (ICER) said in a recent article that the FDA should be…

“Skinny labeling” on 15 generic drugs saved Medicare an estimated $14.6 billion from 2015-2021, but patent lawsuits may threaten the practice, according to an analysis published in the Annals of…

This edition of Quick Notes reviews the FDA’s approval of Medtronic’s closed-loop rechargeable spinal cord stimulator, Abbott’s below the knee Everolimus Eluting Resorbable Scaffold System, an integrated continuous glucose monitor,…

Shouldering the cost of FY25 federal employee pay increases may cause the FDA’s Office of Regulatory Affairs (ORA) to reduce the number of inspections it can conduct, said the office’s…

The Apple Watch’s atrial fibrillation (AFib) history feature is now qualified as the first digital health technology under the FDA’s Medical Device Development Tools (MDDT). Source: Drug Industry Daily

Most of the new oncology indications approved under Real Time Oncology Review (RTOR) relied on surrogate endpoints that were never confirmed as clinically effective in postmarketing trials, according to a…

SonarMed Airway monitors and sensors saw two separate Class I recalls for a restricted inner diameter in the airway and software that failed to detect the partial obstruction, while BioMérieux…