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August 29, 2016
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...
August 4, 2016
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...
June 24, 2016
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...
March 31, 2016
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...
March 30, 2016
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...
January 4, 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...
December 16, 2015
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...
October 8, 2015
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...
October 7, 2015
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...