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…

Patient voice is a key ingredient for both sponsors and regulators in developing new therapeutics for rare diseases, according to the FDA. Source: Drug Industry Daily

Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) have asked the Government Accountability Office (GAO) to conduct a review of the FDA’s oversight of medical device recalls, citing a massive…

After 10 months of questions and concerns from antitrust regulators, Pfizer’s colossal $43 billion acquisition of cancer-focused biotech company Seagan is complete. Source: Drug Industry Daily

Over the past week, the FDA issued draft guidance on advanced manufacturing technologies designation program and announced the establishment of a new advisory committee on genetic metabolic diseases. Source: Drug…

The FDA has released a revised Manual of Policies and Procedures (MAPP) on ANDA labeling revisions to reflect certain changes mandated by lawmakers late last year. Source: Drug Industry Daily

Manufacturers of 48 Medicare Part B drugs raised their prices faster than inflation in the last quarter of 2023 — in some cases even in each quarter over the past…