Regulatory Update – July 2019
FDA: Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and
Category: Regulatory Updates
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
Regulatory Update – April 2019
Applying for a Certificate of Pharmaceutical Product in a no deal scenario Read more… CDER: Assessing the Structural and Pharmacological
Regulatory Updates – March 19
US FDA: Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry Read more… US FDA: Product-Specific Guidance’s for Generic Drug