Health Advisory: FDA Announces New Regulatory Requirements for Certain PET Drugs; All Production to be Treated as Manufacturing
4/1/2000
This advisory discusses the Food and Drug Administration's (FDA) decision to regulate all production of positron emission tomography (PET) drug as manufacturing requiring pre-market approval. The issue also discusses the FDA's decision to waive, for two commonly used PET drugs for certain indications, the usual requirement that each marketing application contain proof of safety and efficacy. Topics discussed include the impact that less regulation of PET products will have on the PET community, the origins of the FDA's announcement (Syncor International Corp. v. Shalala, 127 F.3d 90 (D.C.Cir. 1997), and the FDA Reform Bill.
