Tag: USA Regulatory News

Medical Devices-USA/Europe Regulatory News – Nov 2023

Medical Device

USA Guiding Principles on Predetermined Change Control Plans for Machine Learning-Enabled medical devices FDA, Health Canada, and MHRA jointly identified 5 guiding principles (Focused and bounded,...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Pharma/Biotech – USA, Europe Regulatory News, Oct 2023 Vol. 1

Biopharma

USA FDA Draft Guidance Pushes for Development of Stimulant Use Disorder Treatments With no FDA drug approvals to date for stimulant use disorder, the FDA published draft guidance outlining current...

Biotech Regulatory News, Combination Products, EU Regulatory News, Marketing Authorisation, Pharma Regulatory News, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-October 2023

Medical Device

USA Electronic Submission Template for Medical Device 510(k) Submissions The FDA Electronic submission template for medical device guidance describes the technical standards associated with...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-September 2023

Medical Device

USA (FDA) Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors The FDA has released guidance designed to support institutional review boards (IRBs), clinical investigators,...

CE marking, Europe Regulatory News, in vitro diagnostics, Medical Devices, Regulatory News, USA Regulatory News, vigilance

Pharma/Biotech – USA, Europe Regulatory News, July 2023 Vol. 1

Biopharma

USA CMS IRA Updates Bring No Significant Strategic Shift for Manufacturers Despite ongoing lawsuits and thousands of public comments, CMS has made limited adjustments to the drug price negotiation...

Biotech Regulatory News, EMA, EU Regulatory News, FDA, GCP Guideline, MHRA, Pharma Regulatory News, Regulatory News, RWD, RWE, USA Regulatory News

Pharma/Biotech – USA, Europe Regulatory News, June 2023 Vol. 1

Biopharma

USA The FDA Issues Development Program Guidance’s to Assist Drug, Device Sponsors The The The FDA issued multiple guidance document’s on Friday to help sponsors conduct drug-drug interaction...

Biotech Regulatory News, EU Regulatory News, European Medicines Agency, Pharma Regulatory News, Regulatory News, US FDA, USA Regulatory News

Tag: USA Regulatory News

Medical Devices-USA/Europe Regulatory News – Nov 2023

Pharma/Biotech – USA, Europe Regulatory News, Oct 2023 Vol. 1

Medical Devices-USA/Europe Regulatory News-October 2023

Medical Devices-USA/Europe Regulatory News-September 2023

Pharma/Biotech – USA, Europe Regulatory News, July 2023 Vol. 1

Pharma/Biotech – USA, Europe Regulatory News, June 2023 Vol. 1

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