Blog Category: Biopharma

Asia/ROW BioPharma Regulatory 2023 News/Updates recap

Biopharma

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

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

Biopharma

USA Significant Public Response to FDA’s Proposed Oversight of Laboratory-Developed Tests The FDA has received over 2,100 comments on its proposed rule to regulate laboratory-developed tests...

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

Pharma/Biotech – Asia, ROW Regulatory News, Nov. 2023 Vol. 2

Biopharma

ASIA MALAYSIA Revised Guideline for Facilitated Registration Pathway (FRP) Malaysia’s NPRA has updated its Facilitated Registration Pathway (FRP) guideline. The revised framework now includes...

Asia Regulatory News, BioTech, Conditional Approval, Facilitated Registration Pathway, Pharma, Regulatory Updates, ROW Regulatory News, Therapeutic Goods

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

Biopharma

USA The U.S. FDA Publishes Two Final Guidance’s on Technical Specifications for Clinical Data The The U.S. FDA released a pair of final guidance’s Friday meant to assist drug makers by providing...

Pharma/Biotech – Asia, ROW Regulatory News, Oct. 2023 Vol. 2

Biopharma

ASIA Pakistan DRAP outlines pharma implications of Pakistan’s hazardous waste policy The Drug Regulatory Authority of Pakistan (DRAP) has shared details about how national guidance reports...

Asia Regulatory News, BioTech, Pharma, Regulatory Updates, ROW Regulatory News

Understanding FDA Labeling Regulations

All labels and other written, printed or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The U.S. Food and Drug Administration (FDA) holds that labeling...

Compliance Guide, Drug Labeling, FDA, Labeling Guidelines, Labeling Regulations