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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
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
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
Upcoming events in the coming weeks include nine FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on calculating sample sizes for verification and validation activities and medical device counterfeiting. Read More
Over the past week, the FDA issued guidance on its intention not to take action to enforce the requirements of DSCSA until Nov. 27, 2024, recommendations on system attributes necessary to enable secure tracing of products at the package level under DSCSA, formal dispute resolution on pharmaceutical GMP scientific and technical issues, and use of real-world data to support regulatory decision making. Read More
Our coverage spans a bone graft product that caused a tuberculosis infection, a subcutaneous cancer treatment, a warning letter for an eye drop manufacturer, 300 higher risk patients with a recalled Medtronic cardiac pump, and a lawsuit by Insulet against a competitor for intellectual property theft. Read More
Upcoming events in the coming weeks include ten FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on calculating sample sizes for verification and validation activities and medical device counterfeiting. 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
Over the past week, the FDA issued a draft guidance on product-specific guidances, extended the comment period on a draft guidance for human cellular and gene therapy products, published a list of bulk drugs for which there is a clinical need under section 503B of the FD&C Act and notices of advisory committee meetings for oncologic drugs, endocrinologic and metabolic drugs and vaccines and related biological products. Read More
The FDA has announced a new testing tool, and approved several systems for cryoablation, donor lung preservation and cervical disc replacement. Read More
This European Edition of Quick Notes includes a Swissmedic study of drug approval times, $16 million awarded by UK Innovate, an announcement by Roche of phase 3 anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) preliminary results and an Access to Medicine Foundation report on antimicrobial resistance and responsible manufacturing. Read More
Upcoming events in the coming weeks include seven FDA advisory committee meetings as well as the the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, and webinars from FDAnews, a WCG company on medical device risk management tools and calculating sample sizes for verification and validation activities. Read More