FDA Releases Draft Guidance on Bioequivalence Requirements for ANDA Applicants
By EsqSocial Corporation 06/12/13
On December 4, 2013, the U.S. Food and Drug Administration (FDA) issued a draft guidance on demonstrating bioequivalence for drugs submitted under an Abbreviated New Drug Application (ANDA). Entitled Bioequivalence Studies with Pharmacokinetic...
By: Duane Morris LLP