The FDA issued draft guidance to introduce De Novo request submitters to the current resources and associated content developed and made available to support medical device De Novo electronic submissions to the Center for Devices and Radiological Health (CDRH) and...
FDA published draft guidance on decentralized clinical trials for Drugs, Biological Products, and Devices that provides recommendations on the implementation and design of clinical trials where some or all of the trial-related activities occur at locations other than...
From ECA Academy FDA’s Center for Devices and Radiological Health (CDRH) published a list of new guidances planned for fiscal year 2023 (1 October 2022 – 30 September 2023). The CDRH divides the list into an “A” and a “B” priority....
The ICH Q9(R1) Guideline on Quality Risk Management reached Step 4 of the ICH Process. This Guideline is intended to provide guidance on the principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical...
MWA is pleased to announce that Michelle Hoover has joined our team as Account Manager. Michelle is an experienced client services leader in the pharmaceutical industry in areas of Contract Manufacturing, Supply Chain, and Development. She has over ten years of...
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