Clinical Research Solutions
FDA Generic Drug User Fee Rates: Fiscal Year 2017
FDA has announced its 2017 user fee rates related to the Generic Drug User Fee Program, which includes: Abbreviated new drug applications (ANDAs) Prior approval supplements (PASs) to an approved ANDA...
Clinical Research Solutions
CREATES Act: Bipartisan Bill to Help Generic Drug Makers Obtain Samples Needed for Clinical Trials
On Tuesday, June 14, the “Creating and Restoring Equal Access to Equivalent Samples Act of 2016” (CREATES Act) was introduced by members of the Senate Judiciary Committee. This bipartisan bill...
Clinical Research Solutions
Everything You Should Know about FDA’s Draft Guidance on Abuse-Deterrent Generic Opioids, Part Two
FDA Touches on Routes of Abuse, Comparative In Vitro Studies, and Various Other Factors to Consider Regarding Abuse-Deterrent Generic Opioids Due to recent increases in the prevalence of opioid abuse...
Clinical Research Solutions
Everything You Should Know about FDA’s Draft Guidance on Abuse-Deterrent Generic Opioids, Part One
Evaluating the Abuse Deterrence of Generic Opioid Drug Products As we recently reported, the prevalence of opioid abuse and overdose have reached epidemic levels in the U.S. over the past decade. In...
Clinical Research Solutions
FDA: Major Rule on Generic Drug Labeling Changes to Come in Summer 2016
In November 2013, the FDA introduced a proposed rule entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.” Last month, the Agency announced the...
Clinical Research Solutions
Woodcock Announces CDER’s 2016 Priorities & Says ANDA Backlog was the Biggest Challenge of GDUFA I
On Monday, December 14th, the director of FDA's Center for Drug Evaluation and Research (CDER), Janet Woodcock, M.D., spoke at the FDA/CMS Summit for Biopharma Executives where she announced the...
Clinical Research Solutions
Senator: FDA’s Backlog of ANDAs is Causing “Harm” to Consumers
On September 28, 2015, Sen. David Vitter (R-LA) sent a letter to FDA’s Acting Commissioner, Stephen Ostroff, MD, in which he stated various concerns regarding an extensive backlog of Abbreviated New...
Clinical Research Solutions
Could Pharmaceutical “Product-Hopping” Violate Antitrust Laws? FTC Thinks So…
In the case between Mylan Pharmaceuticals and Warner Chilcott, in which Mylan accused Warner Chilcott of violating antitrust laws by participating in “product hopping”, the FTC has filed an amicus...
Clinical Research Solutions
FDA Guidance Finalizes Generic Drug Makers' Process for Communicating with the Agency
This week FDA finalized its draft guidance on Controlled Correspondence Related to Generic Drug Development. Although all submitted comments were considered, FDA’s revised the draft to “provide...
Clinical Research Solutions
FDA Prepares for GDUFA Commitments with Controlled Correspondence Guidance
With the implementation of GDUFA, FDA defined the rules and specific protocol for submitting controlled correspondence to the Office of Generic Drugs (OGD) in a draft guidance published on August 27,...