“Generic Drug User Fees (GDUFA) – How Do They Impact ANDA Applicants and Type II DMF Holders?”
In this webinar, Prabu Nambiar, Ph.D. MBA, RAC,CMC Consultant to The Weinberg Group Inc., helps life science executives appreciate the value of user fees in an FDA-regulated world
Evaluating Product Risk in a Rapidly Changing Environment – Webinar
In this webinar, Matthew Weinberg, CEO, The Weinberg Group Inc., helps corporate leadership better understand how to weigh risks and benefits in a changing environment.
FDA User Fees – What Have They Done For You Lately – Webinar
FDA user fees have been fact of life for regulated industry for nearly two decades. As you continue to comply by paying the fees, you should understand what the revenue does for you. This webinar will provide a history of the Prescription Drug User Fee Act (PDUFA) from its inception to its latest reauthorization (PDUFA […]
ANDA vs. 505(b)(2) – When and Why? – Webinar
In this webinar, Dr. Nick Fleischer, Vice President, The Weinberg Group, helps regulatory executives understand some of the nuances of the ANDA and 505(b)(2) regulatory pathways.