Cadoret Global

FDA, MHRA, Health Canada Joint GCP Symposium Focuses On 3 Key Topics The FDA, the U.K. MHRA, and Health Canada recently came together for a symposium on GCP with focus on the ICH E6 harmonized guideline and two other key topics. Preparing For FDA's START Program: Rare Disease Drug Developers Delve into this overview of the U.S. Food and Drug Administration's START pilot program, expectations to consider if you are applying to the program, and early preparation considerations.

By Enith Morillo, Cadoret Global The U.S. FDA, the U.K. Medicines & Healthcare products Regulatory Agency (MHRA), and Health Canada (HC) recently came together for a three-day symposium on good clinical practices (GCP). The primary focus areas of the symposium were the ICH E6 harmonized guideline, remote regulatory assessments, and good pharmacovigilance practices. This article shares the key highlights and takeaways.

By Enith Morillo, Cadoret Global Throughout the pandemic, the FDA has demonstrated more than ever the value of using a risk-based approach to inspectional activities, which must be embraced and mirrored in industry when it comes to supplier and vendor audits, especially by early-stage pharmaceutical companies. Article | By Brian Ball, Nikka Densok USA, Inc. High voltage leak detection (HVLD) is a technology first applied to pharma manufacturing in the 1970s.