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July 3, 2018
On Monday, June 25th, FDA approved GW Pharmaceuticals’ Epidiolex (cannabidiol) for the treatment of two rare and severe forms of epilepsy. Epidiolex is the first FDA-approved drug that contains a...
June 29, 2018
On Wednesday, June 20th, FDA announced the availability of a draft guidance entitled "Prescription Drug User Fee Waivers, Reductions, and Refunds for Drug and Biological Products." The guidance is an...
March 26, 2018
On Monday, March 19th, the FDA officially began a new Clinical Data Summary Pilot Program. This program is intended to “assess the feasibility of using a different format to provide required...
March 24, 2018
On Friday, March 16th, the FDA published a notice in the Federal Register, stating that the effective date for the amendments related to intended use would be delayed indefinitely. In the notice, the...
March 5, 2018
On Saturday, February 24, 2018, Health and Human Services (HHS) Secretary, Alex Azar announced that the FDA would be issuing guidance documents regarding expanded access to medication-assisted...
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 2017,...
February 1, 2018
On Monday, January 29, 2018, Roche announced that FDA granted Breakthrough Therapy Designation for balovaptan, the company’s investigational oral medicine for the treatment of autism spectrum...
October 31, 2017
Last month, the FDA launched a new tool that allows users to search for data on the adverse events associated with drug or biological products, which was added as a dashboard to FDA’s Adverse Event...
October 19, 2017
7 Things to Consider Before Selecting a CRO: Selecting the right contract research organization (CRO) is one of the most important decisions you, as a sponsor, must make. That’s because CROs can...