FDA PROVIDES NO RATIONALE FOR ALERT After the Warning Letter for Zhejiang Jiuzhou Pharmaceutical Co. was published in a recent Blog (8/20/14), several of my colleagues sent me comments regarding this Chinese Active Pharmaceutical Ingredient (API) source. They were particularly intrigued by the Blog because one had observed an Import Alert that was issued by the FDA on March … [Read more...]
FDA Warning Letters – Their Relationship to Drug Shortages — An Interesting Counterpoint
Recently (June 12, 2014) I authored a Blog re: “FDA Warning Letters – Their Relationship to Drug Shortages”. This Blog elicited several very interesting comments. Within this Blog, I noted that Douglas C. Throckmorton, MD, Deputy Director for Regulatory Affairs, CDER, FDA recently presented at the ISPE meeting on June 4, 2014 where he discussed this topic and illustrated the … [Read more...]
