During 2011 CDER released a number of new Guidance for Industry documents. Many of these documents are quite difficult to locate within knowing the exact name of the document. These documents include the very widely publicized Process Validation (January 2011), several relating to PET (Positron Emission Tomography) products and their approvals, as well … [Read more...]
MEDIA FILLS FOR VALIDATION OF ASEPTIC PREPARATIONS FOR POSITRON EMISSION TOMOGRAPHY (PET) DRUGS
CDER RELEASES A NEW PET DRAFT GUIDANCE CDER has just released as a DRAFT the following Guidance for Industry, "Media Fills for Validation of Aseptic Preparation for Positron Emission Tomography (PET) Drugs. The Comment period will be 90 days. Please visit http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273766.pdf to obtain this DRAFT … [Read more...]
Baxter Receives Warning Letter Puerto Rico 1/27/11
Baxter Receives Warning Letter (1/27/11) Baxter received a FDA Warning Letter yesterday (January 27, 2011) for two of its facilities in Puerto Rico. The Warning Letter was announced by Baxter. The FDA has not issued the Warning Letter on its Web site as of Friday, January 28, 2011 … [Read more...]
FDA’s Guidance for Industry Process Validation Issued Today
JUST RELEASED -- January 24, 2011 Guidance for Industry Process Validation: General Principles and Practices; Current Good Manufacturing Practices (CGMP), Rev 1. January 2011. Please contact: Barry A Friedman, PhD at barryafriedman@aol.com for a copy … [Read more...]
