Clinical Research Solutions
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...
Clinical Research Solutions
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On Wednesday, June 20th, FDA announced the availability of a draft guidance entitled "Prescription Drug User Fee Waivers, Reductions, and Refunds for Drug and Biological Products."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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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,...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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 improve efficiency and increase productivity,...
Clinical Research Solutions
FDA Meetings: How to Prepare for FDA Type B Meetings
The Food and Drug Administration has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND Meeting, the second is the End of Phase 2 (EOP2)...