Newsletter - November 21, 2019
Lessons from the Dollar Tree Warning Letter
Last week’s FDA Warning Letter to Dollar Tree stores should act as a warning to all companies that use contract manufacturers particularly that using overseas manufacturers of FDA regulated products. Dollar Tree’s problems relate to its failure to verify the GMP compliance status of its vendors and failure to heed FDA’s repeated notifications of the same. Read More
Two FDA Breakthrough Drug Approvals Highlight Progressive Regulators
Two new drug approvals for rare and life-threatening diseases, both with the Breakthrough therapy designations, show how it is getting common from FDA to approve new drugs based on single clinical trials with smaller sample sizes. The first case is a drug invented in China for a rare cancer, mantle cell lymphoma, was approved based on data...Read More
Lessons from the Dollar Tree Warning Letter
Last week’s FDA Warning Letter to Dollar Tree stores should act as a warning to all companies that use contract manufacturers particularly that using overseas manufacturers of FDA regulated products. Dollar Tree’s problems relate to its failure to verify the GMP compliance status of its vendors and failure to heed FDA’s repeated notifications of the same. Read More
Two FDA Breakthrough Drug Approvals Highlight Progressive Regulators
Two new drug approvals for rare and life-threatening diseases, both with the Breakthrough therapy designations, show how it is getting common from FDA to approve new drugs based on single clinical trials with smaller sample sizes. The first case is a drug invented in China for a rare cancer, mantle cell lymphoma, was approved based on data...Read More
