Clinical Research Solutions
Clinical Quality Systems & the Outsourced Model
The landscape of clinical trials is evolving. The changes that are happening are due to the increased number of FDA-regulated trials, as well as a rise in the complexity of clinical protocols. As...
Clinical Research Solutions
How Important are Clinical Trials in Today’s World of Regulation?
Eliminating clinical trials would be extremely detrimental to the safety and well-being of people all over the world. On Friday, February 24th, The Washington Post published an article written by...
Clinical Research Solutions
#10: Investigator Responsibilities – Protecting the Rights, Safety, & Welfare of Study Subjects
In October 2009, the FDA issued a guidance document regarding its expectations for investigators during the conduct of clinical investigations.The guidance, entitled Investigator...
Clinical Research Solutions
Multi-Regional Clinical Trials 102: Clinical Trial Design & Protocol-Related Issues
Additional information on the guidance document is available in our preceding FDA News article entitled "Multi-Regional Clinical Trials 101: Value, Requirements, and Key Considerations Associated...
Clinical Research Solutions
Multi-Regional Clinical Trials 101: Value, Requirements, and Key Considerations Associated with MRCTs
On Friday, September 9th, the FDA announced the availability of a draft guidance entitled “E17 General Principles for Planning and Design of Multi-Regional Clinical Trials.” The draft guidance, which...
Clinical Research Solutions
FDA Embarks on Warning Letter “Rampage”
Last week the FDA released an astonishing 23 warning letters along with an import alert to a number of companies located across the globe. According to a recent article from Law360, the letters were...
Clinical Research Solutions
EMA Recommends Suspension of Numerous Drugs Due to Faulty Testing
On Friday, July 22nd, the European Medicines Agency (EMA) recommended the suspension of hundreds of drugs that had undergone bioequivalence testing at Semler Research Centre Private Ltd., a clinical...
Clinical Research Solutions
FDA Addresses Extrapolating Adult Data for Pediatric Use
In 2004, the FDA issued a guidance document, entitled “Premarket Assessment of Pediatric Medical Devices.” The guidance stated that, when consistent with scientific principles, data can be...
Regulatory Sciences
FDA Draft Guidance When Developing Chewable Tablets, Part Two
Additional information on FDA’s draft guidance is available in our preceding FDA News article, entitled “FDA Issues Draft Guidance On Quality Attributes to Consider When Developing Chewable Tablets,...
Clinical Research Solutions
FDA Issues Draft Guidance On Quality Attributes to Consider When Developing Chewable Tablets, Part One: Introduction & Overview
On Thursday, June 17th the FDA issued a draft guidance entitled “Quality Attribute Considerations for Chewable Tablets.” The document “describes the critical quality attributes that should be...