This edition of Quick Notes highlights a permanent injunction against a manufacturer of dietary supplements, request for improved post-market evidence standards, a study on lessening cyber threats to legacy devices,…

Companies that make pharmaceutical, biologic and medical devices are caught hiding relevant information or purposefully delaying applying for patents at the U.S. Patent & Trademark Office (USPTO) in gamesmanship moves…

An uncontrolled arm that rotated after operation stopped caused Asensus Surgical’s recall of its Senhance surgical system, which has been identified by the FDA as a class I recall, the…

Dr. Reddy’s Laboratories Telangana, India, facility received yet another FDA Form 483 after an Oct. 19-27 inspection resulted in a 25-page report detailing powdery residue in multiple places on floors…

Over the past week, the FDA issued final guidance on assessing credibility of computational modeling and simulation in medical device submissions and notifying FDA of a permanent discontinuance or interruption…

Two oncology drugs that hold the records for the longest-marketed accelerated approval cancer drugs without confirmed clinical benefit and safety profiles need shorter, more focused study in a subgroup, members…

In this edition of Quick Notes, we review marketing authorization for chlamydia and gonorrhea at-home sample collection kits, FDA guidance on notifying the agency of device discontinuances or interruptions, assessing…

An Arizona company marketing an unapproved vaginal contraceptive cream has settled a federal complaint and agreed to stop distributing the product until the company complies with the Federal Food, Drug,…

The FDA has published 40 new and revised product-specific guidances (PSG) which provide recommendations for developing generic drugs and generating evidence to support ANDA approvals. Source: Drug Industry Daily

A groundbreaking treatment for sickle-cell disease and transfusion-dependent β-thalassemia using the biomedical advancement of CRISPR technology has been authorized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for…