Tag: EU Regulatory News

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

May 4, 2023
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

April 5, 2023
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

March 7, 2023
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outlined drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draft guidance....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

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

February 3, 2023
Biopharma

US FDA Issues Draft Guidance on Developing Drugs for Treatment of Acromegaly Sponsors developing drugs for treating acromegaly should assess the relationship between doses and/or exposure-response...

BioTech, Biotech Regulatory News, EU Regulatory News, Pharma, Pharma Regulatory News, Regulatory Updates, USA Regulatory News