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.
A lack of procedures for receiving, reviewing and evaluating complaints by a formally designated unit is one of nine observations that an FDA investigator made during a Dec. 5-9, 2022, inspection of San Diego-based Integrated Orbital Implants. Read More
A lack of conclusions or follow-up in written records of investigations into unexplained discrepancies since 2020 for Duopa Intestinal Gel (levodopa-carbidopa) prompted FDA investigators to issue a Form 483 to AbbVie’s North Chicago, Ill., facility following a Jan. 23-31 inspection. Read More
A June 22 FDA warning letter to API manufacturer Chengdu KeCheng Fine Chemicals details an October 2022 conversation in which the firm’s general manager told the FDA that his company was not shipping products to the U.S. Read More
An FDA advisory committee voted 10 to 4 to recommend Ipsen Biopharmaceuticals’ palovarotene as an effective therapy for the ultra-rare bone disease fibrodysplasia ossificans progressiva (FOP), which causes tendons and ligaments to be replaced by bone. Read More
The European Academy of Paediatrics (EAP) and 22 other European medical associations have written to the European Commission (EC) to warn that critical pediatric medical devices are being squeezed out of the market by the high cost of implementing the EU Medical Device Regulation 745/2017 (EU MDR). Read More
The FDA’s interpretation and policies on exemption as well as prohibition of wholesaling of compounded drugs in section 503B of the Food, Drug & Cosmetic Act (FDC) are explained in a draft guidance published on June 27. Read More
Receiving oncology study submissions that propose a too-wide range of types and formats of real world data (RWD) — along with a lack of basic elements of study design — has prompted the creation of the FDA’s new Oncology Quality, Characterization, and Assessment of Real-world Data (QCARD) Initiative. Read More
Upcoming events in the coming weeks include three FDA advisory committee meetings as well as webinars on the FDA's sterilization pilot and design control. Read More
WHO and the International Council for Harmonisation (ICH) plan to establish a unified language that streamlines global regulatory decision making on the safety and efficacy of drugs, while offering insights into the scope, causes and consequences of diseases. Read More
A new FDA draft guidance details what to include in a submission for regulatory approval of patient-matched guides used in pre-surgical planning for 3-D printed orthopedic implant systems such as knee or hip replacements. Read More
When communicating about the efficacy and risks of prescription and OTC drugs directly to consumers, quantitative information “can improve consumers’ accuracy in estimating the drug’s benefits and risks” and should be “accurate and understandable” says the FDA in a final guidance issued Tuesday. Read More
There’s a need to tap into a greater array of data sources, identify and consider research questions earlier on, and speed up the generation of real-world evidence (RWE), according to a report from the EMA released Monday. Read More