Tag: Regulatory News

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

July 12, 2023
Biopharma

USA No Big-Picture Impact for Manufacturers in CMS IRA Updates In the face of multiple lawsuits and 7,500 public comments, CMS adjusted some aspects of the Inflation Reduction Act’s drug price...

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

Medical Devices-USA/Europe Regulatory News-July 2023

July 11, 2023
Medical Device

USA (FDA) Content of Premarket Submissions for Device Software Functions The purposes of this document, FDA refers to a software function that meets the definition of a device as a device software...

Europe Regulatory News, FDA, HPRA, Medical Devices, MHRA, Premarket Approval (PMA), Regulatory News, USA Regulatory News

Medical Devices-Asia and ROW Regulatory News-June 2023

June 20, 2023
Medical Device

ASIA INDIA (CDSCO) 2023.06.02_MDR_Final G.S.R. 409(E)_Amendment in Rule 18 and 19 for notifying State MDTL The State Government may, by notification, establish State Medical Devices Testing...

Asia Regulatory News, Implantable Medical Devices, In-vitro Diagnostic, IVD, Medical Devices, Regulatory News, ROW 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