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The FDA’s guidance on showing effectiveness through a single trial plus confirmatory evidence is off to a good start in offering direction on leveraging real-world data (RWD), but providing more specifics would be highly beneficial, industry comments say as comments close on the agency’s draft guidance. Read More
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 on the approvability of the drug itself. Read More
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
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
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on thresholds of unspecified impurities in topical ophthalmic drug products, according to comments on the FDA’s October draft guidance on the subject.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