We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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. Read More
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 year — and the drugmakers will now face stiff penalties under the year-old Inflation Reduction Act (IRA), the White House said. Read More
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. Read More
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 European Commission (EC) directing the company to divest Grail. Read More
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. Read More
The FDA has announced a new Genetic Metabolic Diseases Advisory Committee (GeMDAC) to help the agency explore the complex issues related to genetic metabolic disease drug development. Read More
This edition of Quick Notes looks across the pond at Europe’s new critical medicines list, reference labs for high-risk IVDs, guidelines for adverse reaction follow-ups and a tweaked website. Read More
According to a poll released this week by the Biotechnology Innovation Organization (BIO), U.S. voters would support a bill introduced in September to fix a provision in the Inflation Reduction Act (IRA) that disincentivizes drug companies from discovering multiple rare disease applications for the same medicine. Read More
Upcoming events in the coming weeks and months include two FDA advisory committee meetings; and MAGI 2024: The Clinical Research Conference in New Orleans. Read More
Novartis and Lupin are seeking additional clarity on thresholds of unspecified impurities in topical ophthalmic drug products, according to comments on the FDA’s October draft guidance on the subject. Read More
Under a new program, described in a draft guidance issued Tuesday, the FDA will expedite development and assessment of applications, including supplements, for drugs that are manufactured using a designated advanced manufacturing technology (AMT). Read More