We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Over the past week, the FDA issued a draft guidance on product-specific guidances, extended the comment period on a draft guidance for human cellular and gene therapy products, published a list of bulk drugs for which there is a clinical need under section 503B of the FD&C Act and notices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
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 final guidance on informed consent and premarket notification for magnetic resonance devices and extended the comment period for a draft guidance on demonstrating bioequivalence for type A medicated articles containing certain active pharmaceutical ingredient(s). Read More
Recent clearances and approvals of medical devices include not just new versions of existing products, but entirely different ways to provide care for both complex illnesses and common needs. 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 a webinar from FDAnews, a WCG company on medical device risk management tools. Read More
This first European Edition of Quick Notes includes a PDUFA date extension for a chikungunya vaccine candidate, NICE approved AI technologies for radiotherapy treatment therapies, Novartis cited for claims made on an Entresto podcast and comments on the EU proposal for compulsory licensing. 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
Quick Notes
Today’s Quick Notes include a drug shortages survey conducted by the American Society of Health-System Pharmacists, an AARP analysis of drug price increases and a request for comments from the FDA on the development of a technology and software assessment that examines the feasibility of dispensers to meet new requirements. Read More
Over the past week, the FDA issued final guidance on acceptable intake limits for nitrosamines and draft guidances on QTc information in human prescription drug and biological product labeling, classification categories for biosimilars, formal meetings for biosimilars and postmarketing approaches in clinical trials. Read More