Category: Biopharma

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – June 2024

July 8, 2024
Biopharma

USA FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test The U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress...

Biotech Updates, Clinical Trials, Drug Safety, EMA, FDA, Global Health, Healthcare Regulations, Medical Devices, Pharma News, Regulatory News

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – May 2024

June 19, 2024
Biopharma

USA EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology In response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable,...

Bio Pharma, Bio Tech, Biotech News, Biotechnology, Drug Approval, EMA, FDA, Global Health, Health News, Healthcare, Healthcare Innovation, Medical Updates, Pharma Industry, Pharma News, Pharma Regulations, Pharma Trends, Pharma2024, Pharmaceuticals, Regulatory Updates

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – April 2024

May 8, 2024
Biopharma

USA Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs The Food and Drug Administration (FDA or Agency) is announcing the availability...

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – March 2024

April 8, 2024
Biopharma

USA Three FDA Final Guidance’s on Electronic Submission of Safety Reports Three FDA final guidance’s address electronic submissions for reporting adverse reactions — one for investigational...

BioPharma Industry, Global Regulations, Industry News, Pharma Insights, Regulatory Updates

Adopting a Life Cycle Approach to Software Medical Devices: Regulatory Guidelines by Singapore HSA

April 3, 2024
Biopharma

In March 2024, The document “Regulatory Guidance for Software Medical Devices – A Lifecycle Approach” whose third revision was issued by the Singapore Health Sciences Authority. The document is intended...

Cybersecurity, Health Tech, Healthcare Policy, Healthcare Technology, Medical Device Standards, Post Market Surveillance, Product Registration, Quality Management System (QMS), Regulatory Compliance, Singapore Healthcare, Software Regulations

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Feb. 2024

March 7, 2024
Biopharma

USA FDA Modernizes Informed Consent Guidance, Aligning With Common Rule Changes The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made...

Asia Biotech News, Asia Regulations, Biotech News, DSCSA Compliance, EU Regulatory, FDA Updates, Global Healthcare, Pharma Regulations, Singapore Healthcare, Swiss Medic