The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
An HHS watchdog will audit how the FDA inspects generics manufacturing facilities, oversees postmarketing studies and ensures compliance with clinical trial reporting requirements, as well as how the drug industry is implementing the track-and-trace law. Read More
The World Health Organization is seeking public comment on its long-held position that clinical trial sponsors should share their study data in a timely manner, pointing to recent research that finds many results are never published. Read More
Drug sponsors conducting a clinical trial should take efforts to better understand the effects of a particular disease on patients when designing ways to measure patient-reported outcomes, says an FDA clinical trials official. Read More
Regulators in Europe have proposed restricting access to certain information in a forthcoming clinical trials portal and database, but industry wants assurances that the system will be able to differentiate security access for different types of documents. Read More
Drugmakers in Europe are calling for the establishment of a new clinical trial portal and database, rather than modifying existing systems, to meet requirements for a single, streamlined submission process for clinical trial applications. Read More
Manufacturers that sell drugs in the European Union will soon have to make publicly available clinical trial data supporting approval of those products, under a landmark transparency policy adopted yesterday by the European Medicines Agency. Read More
Local and regional medicines authorities need to have mechanisms in place to ensure that clinical trial data quality is preserved in secondary studies, a Washington, D.C.-based think tank says. Read More