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 Drugs (OGD), states that “the timing couldn’t be better amid concerns about rising drug prices.”
The following are important to note about this advancement:
To read the full story, view FDA’s blog post. For additional details and data related to OGD’s 2016 performance, view the Agency’s annual report.
Are you in the process of developing a generic drug? Are you seeking FDA-approval of a generic product? Using our proprietary approach to FDA, we can help with these or any other FDA-related matters. To learn more about our services and how we can help you, contact us today.
March 6, 2017
On Wednesday, February 21st, the FDA released a final rule entitled “Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices.” The new rule amends the Agency’s...
March 6, 2017
On Wednesday, September 28th, the FDA issued a final guidance document regarding the inclusion of the term “healthy” on the labels of food products. The guidance, entitled “Use of the Term ‘Healthy’...
March 6, 2017
Guidance for Industry May 2022 Today, FDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.” Specifically, this...