Regulatory Update – October 2019
FDA: Patient-Focused Drug Development: Methods to Identify What Is Important to Patients (draft guidance) Read More… MDCG 2019-9 Summary of safety
Category: Regulatory Updates
Regulatory Update – September 2019
China’s NMPA releases new UDI guideline (article in Chinese) Read more… India’s NPPA clarifies knee implant price caps amid market
Regulatory Update – July 2019
FDA: Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and
Regulatory Update – June 2019
EMA: Combination Products and MDR: Draft Guideline Read more… WHO: A Framework for Evaluating 3 And Publicly Designating Regulatory 4
Regulatory Update – May 2019
WHO: No Time to Wait: Securing the future from drug-resistant infections Read more… US FDA and Health Canada Joint Regional