In order for a generic drug to be approved by the FDA, the drug maker must prove that the product is pharmaceutically equivalent to its reference listed drug (RLD). There are many different types of evidence that can be used to demonstrate bioequivalence, including in vivo testing, in vitro testing, or a combination of both.
To assist with the development and availability of generic drug products, FDA publishes product-specific recommendations, which describe “the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.” These recommendations are published incrementally and are revised and updated on a regular basis.
On Tuesday, October 4th, the FDA issued 67 product-specific bioequivalence recommendations, of which 34 were new and 33 were revised.
According to an article from RAPS, the Agency “is seeking feedback before finalizing the draft bioequivalence (BE) guidance and the 33 revisions, is focusing on the following new products:
For a full list of the Agency’s product-specific recommendations for generic drug development, visit FDA’s website.
Do any of these recommendations apply to your drug? Have a product that you think is a candidate for an ANDA submission? As the rules and regulations are constantly changing and evolving, we know it can be difficult to stay on top of everything. That is why we are here to help. We can work with you to ensure your product(s) are compliant and that you are up to date with all FDA regulations. To learn more about our services and how we can help you, contact us today.
March 6, 2017
In a recent post on the FDA Voice blog, the Agency reported that its generic drug program hit record highs in 2016. In the blog post, Kathleen “Cook” Uhl, M.D., Director of FDA’s Office of Generic...
February 21, 2017
On Wednesday, February 15th, the FDA issued a revised draft guidance, entitled “Draft Guidance on Difluprednate.” regarding its bioequivalence recommendations for the product. In the revised...
August 29, 2016
On Wednesday, August 24th FDA released a final guidance document, entitled “Abbreviated New Drug Application Submissions – Refuse to Receive for Lack of Justification of Impurity Limits,” which...