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FDA Sets Workshop on Complex Generics

Oct. 4, 2017

The FDA will host a public workshop Oct. 6 on “Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: Advances in Characterization and In Vitro Testing.”

The workshop, from 8:30 a.m. to 4:30 p.m., is intended to share the FDA’s knowledge of the evaluation and characterization of critical quality attributes for complex drug substances, such as polymeric and naturally derived substances and peptides, and for formulations such as liposomes, emulsions, suspensions and polymeric inserts. Participants also will discuss innovative approaches to the development and regulation of the products.

The workshop will take place at the agency’s headquarters in Silver Spring, Maryland.

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