Do the proposed rule and draft guidance apply to PET dugs used in clinical investigations and basic research?
INDs are used to allow investigation of new drugs in order to provide evidence of the drugs’ safety and effectiveness (see 21 CFR, part 312). The proposed regulations and draft guidance apply to all PET drugs, but draw a distinction for PET drugs that are produced under an IND or with the approval of a Radioactive Drug Research Committee (see 21 CFR § 361.1) and used in basic research. The proposed regulation provides that for investigational and research PET drugs, CGMP would be met by producing PET drugs in accordance with Chapter <823> of the 2004 version of the United States Pharmacopeia, “Radiopharmaceuticals for Positron Emission Tomography–Compounding.” All other PET drugs would have to comply with the new regulations proposed for Part 212. 7. How many PET facilities are there? At the time the proposed rule was drafted, there were slightly more than 100 PET facilities. However, the number of PET facilities has been growing rapidly. 8. In what types of establishments are PET drug
Related Questions
- Does the system adhere to the May 2007 Guidance from the FDA on Computerized Systems used in Clinical Investigations (available at http://www.fda.gov/cder/guidance/7359fnl.htm)?
- Do the proposed rule and draft guidance apply to PET dugs used in clinical investigations and basic research?
- Does the final rule apply to PET dugs used in clinical investigations and non-clinical research?
