Select Page

Latest FDA Bioequivalence Guidance on Studies During COVID

FDA Guidance

The Food and Drug Administration (FDA) issued a bioequivalence guidance document in January 2021 to provide recommendations to prospective applicants of abbreviated new drug applications (ANDAs) on ensuring the protection of participants when resuming or initiating bioequivalence (BE) studies conducted to support the approval of an ANDA that have been disrupted during the COVID-19 public health emergency.

Furthermore, the FDA, EMA, and WHO have released specific guidelines on Bioequivalence in addition to the general bioequivalence guidance for clinical trials. These product-specific guidelines outline the agencies’ present perspectives and requirements for developing generic drug products that are therapeutically equivalent to specific reference listed drugs, taking into account the pharmacokinetic properties and safety of the study population.

FDA Guidance for Industry:

Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency

About BioPharma Services Inc.

BioPharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Data Management and Medical Writing.

Popular Posts