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August 22, 2019
On August 7th, the U.S. Government Accountability Office (GAO) published its report on generic drug applications. In the report, GAO comments on the number of products approved on the first review...
October 1, 2018
On Tuesday, September 25th, the FDA issued a guidance document entitled “ANDA Submissions – Content and Format.” The document, initially issued as a draft guidance in June 2014, provides sponsors...
August 21, 2018
Generic drugs are immensely important to the U.S. healthcare system. These drugs account for 89% of the prescriptions dispensed in the United States. And, over the last decade, generic drugs have...
February 15, 2018
Throughout 2017, the FDA focused its attention on the regulation of generic drug products. In 2015, the Agency issued only two generic-related guidance documents. In 2016, there were seven. In...
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On Wednesday, February 15th, the FDA issued a revised draft guidance, entitled “Draft Guidance on Difluprednate.”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...
January 26, 2017
On Wednesday, January 25th, the FDA unveiled a critical data update to Approved Drug Products with Therapeutic Equivalence Evaluations, also referred to as the “Orange Book.” According to the...
October 6, 2016
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...
October 3, 2016
On Thursday, September 22, FDA issued a guidance document, entitled “Self-Identification of Generic Drug Facilities, Sites, and Organizations.” The document was published with the intention of...
