Inspection readiness is more than a quick practice session before the FDA investigator arrives; preparation should begin long before an inspection is even announced, say regulatory experts who advise establishing…
New bipartisan legislation to increase pharmacy benefit manager (PBM) drug price transparency was introduced Friday by the members of the House Energy and Commerce, Ways and Means and Education and…
Failure modes and effects analysis (FMEA) is a useful tool for medical devicemakers but it is no substitute for a risk assessment, said quality expert Eliot Zaiken in an Aug.…
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily
Royal Philips, Amsterdam-based parent company of Philips Respironics, reports that it’s close to settling multiple lawsuits related to Philips Respironics’ voluntary recall of certain sleep and respiratory care devices. Estimated…
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…