Clinical Research Solutions
Only 12% of Generic Drugs Reviewed Were Approved in the 1st Review Cycle, says GAO Report
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...
Clinical Research Solutions
FDA Issues Final Guidance Regarding Content & Format Requirements for ANDA Submissions
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 The document, initially issued as a draft guidance in June 2014, provides sponsors...
Clinical Research Solutions
Generic Failure: Why so Few ANDAs Are Accepted by FDA on the First Pass
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...
Clinical Research Solutions
FDA Steps up its Game on Generic Drugs: The Story Behind the Recent Focus on Generic Products
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 2017,...
Clinical Research Solutions
2016 was Record-Setting Year for Generic Drug Approvals, Reports FDA
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...
Clinical Research Solutions
FDA Responds to Citizen Petition & Publishes Revised BE Recommendations for Difluprednate
On Wednesday, February 15th, the FDA issued a revised draft guidance, entitled “Draft Guidance on Difluprednate.”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...
Clinical Research Solutions
FDA Makes Critical Data Update to the Orange Book
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...
Clinical Research Solutions
FDA Issues 67 New & Revised Bioequivalence Study Recommendations for Generic Drug Makers
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...
Clinical Research Solutions
Self-Identification 101: Everything You Need to Know About FDA’s Self-Identification Requirements for Generic Drug Facilities, Sites, & Organizations
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...
Clinical Research Solutions
FDA Issues Guidance Regarding the Agency’s Refuse to Receive Policy for Certain Abbreviated New Drug Applications
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...