BioSpace reviews the 10 biggest drug approvals of 2021, headlined by Biogen’s Aduhelm (aducanumab) as the first drug approved for Alzheimer’s disease in almost 20 years.
Is Your Quality Management System Ready for Fast Tracked Pandemic Related Drug Approvals?
Business, Coronavirus Disease (COVID-19) Pandemic, COVID-19 Therapeutics, Current Goods and Manufacturing Practice (CGMP), Data, Fast Track, FDA, Investigational New Drug (INDs) submissions, IQVIA, Manufacturing, Medicines, New Drug Applications, New Drug Approvals, R&D, Virtual, Warning LettersMike Hidock, Director of Quality and Compliance Services at IQVIA, analyzes key considerations for preparing quality management systems (QMS) for fast tracked COVID-19 treatment approvals.