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Generic Drugs Agency Alerts

August 22, 2019

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...

Generic Drugs Agency Alerts

October 1, 2018

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 The document, initially issued as a draft guidance in June 2014, provides sponsors...

Generic Drugs General Regulatory

August 21, 2018

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...

Generic Drugs General Regulatory

February 15, 2018

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,...

Generic Drugs Agency Alerts

March 6, 2017

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...

Generic Drugs Agency Alerts

February 21, 2017

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On Wednesday, February 15th, the FDA issued a revised draft guidance, entitled “Draft Guidance on Difluprednate.”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...

Generic Drugs Agency Alerts

January 26, 2017

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...

Generic Drugs Agency Alerts

October 6, 2016

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...

Generic Drugs Agency Alerts

October 3, 2016

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...

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