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,...
Regulatory Sciences
Finding a Roadmap to Approval - Hint: You Can't Pick One Up at the FDA
Earning FDA approval for your drug program is a journey. A misstep at any point of that journey could jeopardize your chance at getting your drug approved. That’s why it’s so important to have a...
Clinical Research Solutions
FDA Takes Steps to Improve Efficiency of Global Pharmaceutical Manufacturing Inspections
On Tuesday, October 31st, the FDA announced that it will begin allowing eight European drug regulatory authorities to conduct inspections of manufacturing facilities and determine whether or not they...
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
Critical Components of Quality Management Systems
Critical Components of Quality Management Systems: In 1962, Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP), which must be compliant...
Clinical Research Solutions
Solar Eclipse 2017: Taking a Look Back
As we’re sure already you know, last week North Americans experienced a total solar eclipse. Leading up to the big event, thousands of articles and blog posts were written about the historical event...