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  CDER has issued a new Draft Guidance as well as a slide deck from B. Uratani, … [Read more...]