Tag: Regulatory News

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

June 6, 2023
Biopharma

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

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

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

May 4, 2023
Biopharma

USA FDA Seeks Comments on Proposed Consumer Rx Advertising Survey The FDA Office of Prescription Drug Promotion (OPDP) is seeking input on its proposal to conduct research into how consumers...

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

Medical Devices-USA/Europe Regulatory News – May 2023

May 3, 2023
Medical Device

USA (FDA) Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions)-Guidance for Industry and Food and Drug Administration Staff This...

Europe Regulatory News, Health Canada, Medical Devices, MHRA, Regulatory News, Swissmedic, US FDA, USA Regulatory News

Medical Devices-Asia and ROW Regulatory News – April 2023

April 18, 2023
Medical Device

ASIA INDIA (CDSCO) Circular for Licensing of Class C & D medical devices According to the Circular It is pertinent to mention that as per Medical Devices rules (MDR) 2017 manufacturing...

Asia Regulatory News, Medical Devices, Regulatory News, ROW Regulatory News, SaMD, Software as a Medical Device

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

April 5, 2023
Biopharma

USA FDA Issues Guidance on ISO Data Standards for Medicinal Products As part of its efforts to harmonize with international standards for exchange of medicinal product data, the FDA has issued...

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

Medical Devices-USA/Europe Regulatory News – April 2023

April 4, 2023
Medical Device

USA (FDA) Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act-Guidance for Industry and Food and Drug Administration...

Europe Regulatory News, FIMEA, HPRA, Medical Devices, MHRA, Regulatory News, Swissmedic, US FDA, USA Regulatory News