Tag: Pharma 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 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

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

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

Biopharma

USA FDA Seeks Comments on Proposed Consumer Rx Advertising Survey The FDA Office of Prescription Drug Promotion (OPDP) is seeking input on its proposal to conduct research into how consumers...

Biotech Regulatory News, EU Regulatory News, European Medicines Agency, Pharma Regulatory News, Regulatory News, US FDA, USA Regulatory News

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

Biopharma

USA FDA Issues Guidance on ISO Data Standards for Medicinal Products As part of its efforts to harmonize with international standards for exchange of medicinal product data, the FDA has issued...

Biotech Regulatory News, EU Regulatory News, European Medicines Agency, Pharma Regulatory News, Regulatory News, US FDA, USA Regulatory News

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

Biopharma

US FDA Offers Advice on Macular Degeneration Drug Trials The FDA outlined drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draft guidance....

Biotech Regulatory News, EU Regulatory News, Pharma Regulatory News, Regulatory News, USA Regulatory News