viernes, 4 de mayo de 2018

OGD Public workshop on generic drug regulatory science initiatives and Webinar on generic drug development

The Office of Generic Drugs (OGD) in the FDA Center for Drug Evaluation and Research announces a free public workshop on generic drug regulatory science initiatives and a free webinar on generic drug development.

May 24, 2018, 8:30-4:30 PM ET

The FDA is hosting the FY 2018 Generic Drug Research Public Workshop to give an overview of the status of regulatory science initiatives for generic drugs. We want your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information obtained from the public workshop into account in developing our fiscal year 2019 regulatory science initiatives. The workshop will be held at FDA’s main campus in Silver Spring, Maryland, on May 24, 2018, from 8:30 a.m.–4:30 p.m. and will be webcast for those who cannot attend in person.

The FDA has extended the deadline for registration. If you are interested in attending, please send an email to You may also suggest generic drug research topics that should be added to the fiscal year 2019 regulatory science initiatives. 
May 17, 2018, 1:00 PM ET 

Speaker: Liang Zhao, Ph.D., Director of the Division of Quantitative Methods and Modeling in the Office of Research and Standards, OGD

Dr. Zhao will discuss novel ways FDA is approaching the use of quantitative methods and modeling for development and demonstration of generic drug sameness. OGD, in collaboration with the Drug Information Association (DIA), hosts this webinar.

REGISTER at no cost!

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