Tag: 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

Medical Devices-USA/Europe Regulatory News – August 2023

Medical Device

USA(FDA) Medical Device User Fee Rates for Fiscal Year 2024 The FD&C Act, as amended by MDUFA V, authorizes FDA to collect user fees for certain medical device submissions and annual fees...

Europe Regulatory News, Harmonised standards, Medical Devices, Regulatory News, Software as a Medical Device (SaMD), USA Regulatory News

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

Biopharma

US FY 2024 Biosimilar User Fees Show Sharp Decrease, Other Fees Increase While prescription drug user fees increased a hefty 19.9 percent and medical device fees a modest 8.7, fees for biosimilar...

Biotech Regulatory News, EU Regulatory News, marketing authorization, Pharma Regulatory News, post marketing requirements, Regulatory News, USA Regulatory News

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

Medical Devices-USA/Europe Regulatory News-July 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

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