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ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

Agency Alerts General Regulatory

July 3, 2018

FDA Approves First Marijuana-Derived Drug for the Treatment of Epilepsy

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...

Agency Alerts General Regulatory

June 29, 2018

FDA Updates Guidance on User Fee Waivers, Reductions, & Refunds

On Wednesday, June 20th, FDA announced the availability of a draft guidance entitled "Prescription Drug User Fee Waivers, Reductions, and Refunds for Drug and Biological Products."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...

Quality & Compliance Agency Alerts

March 26, 2018

First Clinical Study Report Data Published for FDA Pilot Project

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...

Agency Alerts General Regulatory

March 24, 2018

FDA Issues Final Rule to Delay Implementing Parts of ‘Intended Use’ Regulation

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...

Agency Alerts General Regulatory

March 5, 2018

FDA to Expand Medication-Assisted Treatment for Opioid Addiction

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...

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,...

Agency Alerts General Regulatory

February 1, 2018

FDA Grants Breakthrough Therapy Status for Autism Drug

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...

Agency Alerts General Regulatory

October 31, 2017

FDA Launches New & Improved Adverse Event Database for Drugs & Biologics

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...

General Regulatory Regulatory Sciences

October 19, 2017

7 Things to Consider Before Selecting a CRO

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...

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