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Formulating Generic Drug Substances: Overview of FDA Public Meeting

Recently, the Food and Drug Administration (FDA) organized two very interactive public workshops. The first, Demonstrating Equivalence of Generic Complex Drug Substances and Formulation (October 5, 2017) will be outlined here.

The FDA public meetings were to provide an overview of:

  • Current scientific regulations related to drug products that are applied to the skin (topical products)
  • New analytical methods and innovative in vitro testing that could provide evidence of drugs that produce the same effect to facilitate the regulatory review process

Drugs that enter the body through the skin are complex and require strict regulation for demonstrating active ingredients an bioequivalence.

As part of this workshop, speakers from the FDA, as well as leading researchers from several institutions, shared regulatory perspectives and discussed novel in vitro approaches in developing topical products to characterize them and compare bioavailability.

In general, under the description of complex products, the FDA specifies factors such as a mixture of Active Pharmaceutical Ingredients (APIs), matrix composition, delivery into the body, and specific dosage form. During the meeting, discussions on the development of the regulatory framework of generic versions of complex topically applied drugs have attracted broad attention.

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