Tag: Biotech Regulatory News

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 – USA, Europe Regulatory News, Oct 2023 Vol. 1

Biopharma

USA FDA Draft Guidance Pushes for Development of Stimulant Use Disorder Treatments With no FDA drug approvals to date for stimulant use disorder, the FDA published draft guidance outlining current...

Biotech Regulatory News, Combination Products, EU Regulatory News, Marketing Authorisation, Pharma Regulatory News, Regulatory News, USA Regulatory News

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

Biopharma

USA FDA Releases Guidance on EPCIS Standard for DSCSA and Pulmonary Disease Drug Development The FDA has advised that trading partners use the GS1-developed Electronic Product Code Information...

Biotech Regulatory News, EU Regulatory News, Good clinical practice, Pharma Regulatory News, Regulatory News, Risk management, 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

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