Clinical Research Solutions
Sterility Concerns Cause Voluntary Recall of Various Products: Potassium Phosphate & Succinylchoine Chloride
On June 15, 2017, Hospira Inc. issued a voluntary recall of a number of its products after finding a microbial growth during a routine simulation of the manufacturing process, which represents the...
Clinical Research Solutions
FDA Warns Drug Manufacturers of Recalls due to BCC Contamination
On Monday, May 22nd, the FDA issued a warning for drug manufacturers regarding the contamination risk posed by Burkholderia cepacia complex (BCC). According to FDA’s warning, “BCC and other...
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
Indian API Manufacturer Fails to Correct Significant GMP Deviations, Receives FDA Warning Letter
In May 2016, the FDA inspected Resonance Laboratories Pvt. Ltd.’s Bangalore manufacturing facility. During this inspection, the FDA investigator observed a number of significant deviations from...
Clinical Research Solutions
#7: Quality Systems Approach to Pharmaceutical CGMP Regulations
In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative, which explained FDA’s intent of integrating quality systems and risk management approaches, and had a goal...
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...