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)...
Clinical Research Solutions
FDA Aims to Reduce Tobacco-Related Disease & Death with New Plan for Tobacco & Nicotine Regulation
On Friday, July 28, 2017, the FDA released a new, comprehensive plan concerning the regulation of tobacco and nicotine. This multi-year regulatory plan is part of the Agency’s attempt to protect...
Clinical Research Solutions
FDA Issues Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies, Requests Comments
On Tuesday, July 11th, FDA released its draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies for the electronic submission of this...
Clinical Research Solutions
FDA Approves 1st Drug for Sickle Cell Disease in Nearly 20 Years
On Friday, July 7th, the FDA approved Endari (L-glutamine oral powder) to reduce the complications associated with sickle cell disease in patients age five years and older. What is Sickle Cell...
Clinical Research Solutions
FDA to Host Public Workshop to Discuss the Impact of Abuse Deterrent Opioids
On Wednesday, June 14th, the FDA announced plans to host a public workshop regarding the impact of opioid formulations with abuse deterrent properties. The workshop, entitled “Data and Methods for...