Category: Biopharma

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USA FDA Modernizes Informed Consent Guidance, Aligning With Common Rule Changes The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made...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

USA/Europe BioPharma Regulatory 2023 News/Updates recap

February 6, 2024
Biopharma

AUSTRIA User Manual for Marketing Authorisation and Lifecycle Management of Medicines BASG published User Manual for Marketing Authorisation and Lifecycle Management of Medicines. How to login,...

Asia/ROW BioPharma Regulatory 2023 News/Updates recap

February 5, 2024
Biopharma

Asia China NMPA Tightens Regulation on Outsourced Manufacturing for MAHs NMPA issued the Notice on Enhancing the Supervision and Management of Outsourced Manufacturing for Drug Marketing...

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

December 7, 2023
Biopharma

USA Thousands of Comments Pour in on FDA Plan to Regulate Laboratory-Developed Tests As the public comment period closes Monday on the FDA’s rule to regulate laboratory-developed tests (LDT),...

Biotech Regulatory News, EU Regulatory News, Pharma Regulatory News, Regulatory News, USA Regulatory News, Viral Safety Evaluation