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Over the past week, the FDA issued draft guidance on advanced manufacturing technologies designation program and announced the establishment of a new advisory committee on genetic metabolic diseases.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

CDRH has teamed up with three more collaborative device initiatives, including an international effort to leverage the power of AI to improve medical device quality and patient health. Source: Drug…

Illumina announced that it has filed a draft notice to the Securities and Exchange Commission related to its potential divestiture of Grail, pursuant to an order Illumina received from the…

An uptick in drug prices contributed to an increase of 8.4 percent in retail prescription drug spending in 2022, according to a recent CMS report. Source: Drug Industry Daily

Most countries that manufacture excipients don’t require specific data on them or even regulate them highly, a study has found. Source: Drug Industry Daily