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on thresholds of unspecified impurities in topical ophthalmic drug products, according to comments on the FDA’s October draft guidance on the subject.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Under a new program, described in a draft guidance issued Tuesday, the FDA will expedite development and assessment of applications, including supplements, for drugs that are manufactured using a designated…
Actions and future plans by the Biden administration to impose drug price controls could prove disastrous for U.S. clinical trials and medical innovation overall, the U.S. Chamber of Commerce (CoC)…
Comments from AstraZeneca, Pfizer, Johnson & Johnson and Certara on the FDA’s draft guidance on developing peptide drugs focused on ways to categorize peptides and the potential for the drugs…
The FTC announced on Monday its intention to block Sanofi’s proposed acquisition of an exclusive license to Maze Therapeutics’ therapy in development for treatment of Pompe disease and hours later…
AdvaMed announced the establishment of a new medical imaging technology division that will advocate on behalf of large and small devicemakers, and is establishing itself as the new home for…