In the USA, medical devices are regulated within the FDA by the Center for Devices and Radiological Health (CDRH). How can one quickly familiarize oneself with the topic of "medical devices" or stay up to date? For this purpose, the FDA offers an own website: CDRH Learn.
Under the heading "CDRH's Experiential Learning Program", the FDA offers an interesting advanced training program. It is aimed at FDA employees who are "reviewers", i.e. who evaluate medical devices as part of the "approval procedure". The idea behind the program is...
In a draft guideline, the FDA informs that in future they will offer (nonbinding) feedback following an FDA inspection at a medical device manufacturer. What does this mean?
The Biritsh Medicines and Healthcare products Regulatory Agency (MHRA) has published several guidelines for a possible no-deal scenario.
The second Warning Letter within six months reveals fundamental issues in quality management. Learn more about the new FDA warning letter to US company Akorn.
Over and over again, FDA inspectors discover violations of long-established GMP requirements. Read more about which trends in the areas of quality control and production can be identified from the analysis of the Warning Letters issued in the last 21 months.
An Indian manufacturer of solid dosage forms recently received a Warning Letter from the US FDA after the authority had revealed serious deficiencies in the tablet production.
Falsified medicines repeatedly occur in the supply chain. The MHRA now provides information on how to detect them.
New GPD Non-Compliance Reports have been published in the EudraGMDP database, leading to a suspension of the WDA of the inspected companies.
The US FDA has selected four companies to participate in a pilot evaluating blockchain technology to enhance supply chain security.