Tag: USA Regulatory News

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

December 7, 2023
Biopharma

USA Thousands of Comments Pour in on FDA Plan to Regulate Laboratory-Developed Tests As the public comment period closes Monday on the FDA’s rule to regulate laboratory-developed tests (LDT),...

Biotech Regulatory News, EU Regulatory News, Pharma Regulatory News, Regulatory News, USA Regulatory News, Viral Safety Evaluation

Medical Devices – USA/Europe Regulatory News – Dec. 2023

December 6, 2023
Medical Device

USA Food and Drug Administration issued Guidance for Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Guidance describes a nine-step framework...

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

Medical Devices-USA/Europe Regulatory News – Nov 2023

November 7, 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

October 10, 2023
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USA FDA Draft Guidance Pushes for Development of Stimulant Use Disorder Treatments With no FDA drug approvals to date for stimulant use disorder, the FDA has published draft guidance outlining...

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

October 5, 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 preparation...

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

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

September 8, 2023
Biopharma

USA Guidance’s Released on EPCIS Standard for DSCSA Compliance, Pulmonary Disease Drug Development The FDA recommends that “trading partners” use the Electronic Product Code Information...

Biotech Regulatory News, EU Regulatory News, Good clinical practice, Pharma Regulatory News, Regulatory News, Risk management, USA Regulatory News