Tag: Biotech Regulatory News

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

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

October 10, 2023
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USA FDA Draft Guidance Pushes for Development of Stimulant Use Disorder Treatments With no FDA drug approvals to date for stimulant use disorder, the FDA has published draft guidance outlining...

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

September 8, 2023
Biopharma

USA Guidance’s Released on EPCIS Standard for DSCSA Compliance, Pulmonary Disease Drug Development The FDA recommends that “trading partners” use the 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

August 3, 2023
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

July 12, 2023
Biopharma

USA No Big-Picture Impact for Manufacturers in CMS IRA Updates In the face of multiple lawsuits and 7,500 public comments, CMS adjusted some aspects of the Inflation Reduction Act’s drug price...

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

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