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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

The Future of FDA Cosmetics Regulations: What to Expect in the Coming Years

June 5, 2023
Cosmetics

The FD&C Act defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing,...

Cosmetic Compliance, Cosmetics Industry, FDA Cosmetics Regulations, FDA Updates

FDA Regulations for Medical Device Approval in USA

May 29, 2023
Medical Device

FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States. In addition,...

FDA Medical Devices, Medical Device Approval, Pre-market Notification, Quality System Requirements, USA FDA Regulations

AI – Transformation of Regulatory Intelligence in Pharma

May 22, 2023
Biopharma

AI is transforming regulatory intelligence in pharma by providing faster and more accurate access to relevant information. Regulatory intelligence involves monitoring and analyzing regulatory changes...

AI, Artificial Intelligence, Natural Language Processing, NLP, Predictive Analytics, Regulatory Intelligence, Regulatory Reporting, Risk Assessment

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