This edition of Quick Notes looks at new M&A rules, a long overdue separation, conference room procedures, and prescription opioid labeling. Source: Drug Industry Daily

Apple is pausing U.S. sales of its new Series 9 and Ultra 2 Apple watches due to a dispute with Masimo, a monitoring technologies medtech company, that alleges certain Apple…

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published an AI workplan intended to create a collaborative and coordinated strategy that will maximize AI’s benefits while managing…

Despite overall industry support for the FDA’s development of a voluntary Quality Management Maturity (QMM) program for establishments manufacturing drugs, stakeholders raised concerns about a lack of details and the…

The Biden Administration wants to investigate how private equity and other corporations’ increasing power and control of the health care system is affecting Americans. Source: Drug Industry Daily

The FDA’s guidance on showing effectiveness through a single trial plus confirmatory evidence is off to a good start in offering direction on leveraging real-world data (RWD), but providing more…

As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and…

In this edition of Quick Notes, we look at 510(k) clearances for an at-home intravaginal insemination kit, a fingertip blood collection device, first surgical navigation system for total ankle arthroplasty,…

How the FDA evaluates real world data (RWD) to determine if they are of sufficient quality to be used as real world evidence (RWE) in regulatory decision making for medical…

Checkpoint Therapeutics announced that the FDA has issued a complete response letter (CRL) for its cosibelimab BLA based on an inspection of the company’s third-party manufacturer, with no issues cited…