Blog Category: Biopharma

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US FDA Issues Draft Guidance on Developing Drugs for Treatment of Acromegaly Sponsors developing drugs for treating acromegaly should assess the relationship between doses and/or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

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

January 4, 2023
Biopharma

EU EMA recommendation paper: Safety, data integrity key to decentralized trial conduct The European Medicines Agency (EMA), European Commission (EC), and Heads of Medicines Agencies (HMA) recently...

BioTech, Europe Regulatory News, Pharma, Regulatory Updates, US Regulatory News

Biopharma – Europe, USA and Asia Regulatory News, Dec 2022

December 13, 2022
Biopharma

EU ICH M12 on drug interaction studies – Scientific guideline This guideline provides recommendation to promote a consistent approach in designing, conducting, and interpreting enzyme-...

Anti-Infective Drug Products for the Pediatric Population – Guidance from FDA

December 19, 2021
Standards

The US Food and Drug Administration (FDA) issued final guidance to assist sponsors in developing anti-infective drugs for the pediatric population. The guidance provides recommendations for developing...

anti-infective products, antifungals, antiparasitic products, developing anti-infective drugs, development of anti-infective, fda division of anti-infective products, food and drug administration, including antibacterials, pediatric populations

Real World Data and Real World Evidence to Support Regulatory Decision Making for Drug and Biological Products – FDA Draft Guidance

December 11, 2021
Diagnostics

Use of Real World Data and Real World Evidence to Support Regulatory Decision Making for Drug and Biological Products FDA issued the draft guidance as part of its Real World Evidence (RWE) Program...

Drug and Biological Products, FDA Draft Guidance, Real-World Data, Real-World Evidence

Control of Nitrosamine Impurities in Human Drugs

November 26, 2021
Food

FDA is implementing Pharmaceutical Quality/ Manufacturing Standards/ Current Good Manufacturing Practice (CGMP) guidance for the control of nitrosamine impurities in human drugs without prior public...

Control of Nitrosamine Impurities, list of Nitrosamine Impurities, Nitrosamine Impurities guidelines, Nitrosamine Impurities in Drugs, Nitrosamine Impurities in Human Drugs, Nitrosamine Impurity