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Our coverage spans an Abbott acquisition, FDA draft guidances on endogenous Cushing’s syndrome and peptide drug development, EMA guideline revision on clinical trials for depression treatments and a GAO report on drug rebates in Medicare part D. Read More
The FDA’s latest final guidance features questions and answers on how to apply human factors (HF) engineering principles when developing combination products, clarifying how the uniqueness of these products affect HF engineering considerations for industry and agency staff. Read More
Britain and the EU have mended their two-year post-Brexit science funding standoff, as the island nation rejoins Horizon, the EU’s largest source for research collaboration and funding. Read More
Over the past week, the FDA issued final guidance on human factors engineering principles for combination products, treatment of nontuberculous mycobacterial pulmonary disease and supply chain standards. Draft guidances were issued on GDUFA post-warning letter meetings, modernizing the 510(k) pathway, biological evaluation of medical devices, and development of endogenous Cushing’s syndrome and peptide drug products. Read More
The price reduction measures in the Inflation Reduction Act (IRA) could result in 79 fewer small molecule drugs or 188 fewer indications and 116 million life years lost over the next 20 years, a study funded by Gilead Sciences revealed. Read More
The FDA has exercised its new authority to use remote records reviews in lieu of certain types of GMP inspections, issuing a warning letter to Green Pharmaceutical of South Korea based on a review of records it requested on March 3. Read More
This month’s feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG.Read More
The 13 new draft guidelines focused on mergers and acquisitions from the FTC and the Department of Justice (DOJ) go into a lot of detail about what constitutes anticompetitive practices, but they don’t do enough to tell companies what is acceptable when they’re planning a merger or acquisition. Read More
The FDA published three draft guidances Wednesday seeking to modernize the 510(k) pathway and help manufacturers navigate the premarket review process as medical devices become increasing complex and innovative. Read More