DOCUMENTS INCLUDE AN EXTENSIVE SLIDE DECK AND PROPOSED Q & A The FDA has been quite busy since the issuance of the new 21 CFR 212 entitled "Current Good Manufacturing practice for Positron Emission Tomography Drugs" (December 2011) which covers Positron Emission Tomography (PET) Drug Products. CDER has issued a new Draft Guidance as well as a slide deck from B. Uratani, … [Read more...]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CDER RELEASES A NEW PET DRAFT GUIDANCE CDER has just released as a DRAFT the following Guidance for Industry, "Media Fills for Validation of Aseptic Preparation for Positron Emission Tomography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...]
