Category: Biopharma

Pharma/Biotech – Asia, ROW Regulatory News, March 2023 Vol. 2

March 21, 2023
Biopharma

Pakistan Pakistan’s DRAP encourages users to update pharmacovigilance app after recent revisions The Drug Regulatory Authority of Pakistan (DRAP) has asked users of its Med Safety App to update...

Maximizing Success and Mitigating Risk: The Strategic Role of Pharma Regulatory Intelligence Database in the Pharmaceutical Industry

March 14, 2023
Biopharma

Regulatory intelligence refers to the process of gathering and analyzing information about the regulatory landscape, including laws, policies, and guidelines, that may affect a particular industry....

Drug Development, Mitigating Risk, Pharma Regulatory Intelligence, Regulatory Affairs, Regulatory Intelligence, Regulatory Intelligence Database

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outlined drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draft guidance....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 – Asia, ROW Regulatory News, Feb 2023 Vol. 2

February 21, 2023
Biopharma

Asia India WHO calls for action after Asia-made medicines linked to 300 deaths Regulators must take immediate and coordinated action to stop the supply of contaminated over-the-counter cough...

Asia Regulatory News, Australia Regulatory News, BioTech, India Regulatory News, Japan Regulatory News, Malayasia Regulatory News, Pharma, Regulatory Updates, ROW Regulatory News, Saudi Arabia Regulatory News, Singapore 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US FDA Issues Draft Guidance on Developing Drugs for Treatment of Acromegaly Sponsors developing drugs for treating acromegaly should assess the relationship between doses and/or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

Pharma/Biotech – Asia, ROW Regulatory News, Jan 2023 Vol. 2

January 18, 2023
Biopharma

Asia Malaysia Guide for ADR reporters NPRA published guide for ADR reporters which included improving the quality of reports, checklist for ADR reporters. Guideline also includes laboratory...

Armenia Regulatory News, Asia Regulatory News, Baharain Regulatory News, BioTech, India Regulatory News, Malaysia Regulatory News, Pakistan Regulatory News, Pharma, Regulatory Updates, ROW Regulatory News, Saudi Arabia Regulatory News, Tanzania Regulatory News