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This excerpt is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, A WCG Company. The presenter was David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting. Read More
In this edition of Quick Notes, we provide a look at the first dissolvable oral contraceptive, good news for Pfizer’s hemophilia A gene therapy, approval of a new treatment for multiple myeloma and a clinical hold on a Type 1 diabetes therapy. Read More
CDER’s Office of New Drugs (OND) touted accomplishments by the research program it launched in 2019 to address knowledge gaps identified during regulatory reviews. Read More
This edition of Quick Notes features an additional indication approval for Palforzia, phase 3 trial results for AstraZeneca’s Calquence, warning from FDA for compounded semaglutide and FDA approval of an alopecia treatment. Read More
The FDA has long erred on the side of extreme caution when it comes to sharing confidential commercial information and trade secrets out of fear it might violate federal law by disclosing them. Read More
The FDA has developed an AI tool to help its drug application reviewers and researchers identify changes to adverse event (AE) terms made when a drug’s labeling is updated. Read More
With the House and Senate now in recess until Sept. 9, the FDA is once again facing into a new fiscal year unsure of its funding from Congress. Read More
Despite a mostly lukewarm reception to phase 2/3 trial findings, the FDA’s Genetic Metabolic Diseases Advisory Committee voted 11-5 in support of approving Zevra Therapeutics’ arimoclomol for type C Niemann-Pick disease in patients age two years and up. Read More
During the second session of the 118th Congress, FDAnews will track important pending legislation, that has been acted on by Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
A recently published study of new drugs approved by the FDA from 1995 to 2014 showed that sales of most products (75 percent) exceeded the industry-wide costs of development within 10 years. Read More
In an effort to improve access to clinical research in the US and ease enrollment challenges, the Milken Institute has published a new report focusing on distance as a barrier to trial participation, digging deep into demographics and distribution of trials across US counties, as well as offering an interactive map tool filterable by therapeutic area. Read More