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…

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…

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. Source: Drug Industry…

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…

In a new final guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process’”, the FDA provides…

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…

Device manufacturers should be more conscious of potential demographic bias in clinical trials, which could show up as differences in safety, effectiveness or ease of use, according to members of…

This month’s feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Source: Drug Industry Daily

Creating a new medical device classification, the FDA has granted Xenex Disinfection Services’ LightStrike+ high-intensity, broad-spectrum ultraviolet (UV) light robot a De Novo marketing authorization. Source: Drug Industry Daily

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,…