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
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. Source: Drug Industry…
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. Source:…
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…
Upcoming events in the coming weeks and months include two FDA advisory committee meetings; and MAGI 2024: The Clinical Research Conference in New Orleans. Source: Drug Industry Daily
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on thresholds of unspecified impurities in topical ophthalmic drug products, according to comments on the FDA’s October draft guidance on the subject. Source:…
Under a new program, described in a draft guidance issued Tuesday, the FDA will expedite development and assessment of applications, including supplements, for drugs that are manufactured using a designated…