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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 standard operating procedures that will maintain a constant and thorough state of readiness. Read More
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 the Workforce committees. Read More
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. 24 webinar from FDAnews, a WCG company. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
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 amount: $616 million. Read More
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
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 information on using ISO 10993-1 for evaluating devices that come into direct contact with intact skin, including the types of information that should be included in premarket submissions. 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