FDA cGMP requirements for PET drugs

Production of research PET drugs under an Investigational New Drug (IND) application or under the authority of an institutional Radioactive Drug Research Committee (RDRC) may follow either the cGMP regulations in 21 CFR Part 212 or the current United States Pharmacopeia (USP; 32nd edition) General C...

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Veröffentlicht in:	The Journal of nuclear medicine (1978) 2011-05, Vol.52 (5), p.16N-16N
Hauptverfasser:	Norenberg, Jeffrey P, Schwarz, Sally, VanBrocklin, Henry
Format:	Artikel
Sprache:	eng
Schlagworte:	CFR Clinical medicine Commerce - legislation & jurisprudence Drug Approval - legislation & jurisprudence Facility Regulation and Control - legislation & jurisprudence Federal regulation Manufactured Materials - economics Manufactured Materials - standards Meetings Pharmaceutical industry Positron-Emission Tomography - standards Radiopharmaceuticals - economics Radiopharmaceuticals - standards Tomography United States United States Food and Drug Administration - legislation & jurisprudence
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Beschreibung
Zusammenfassung:	Production of research PET drugs under an Investigational New Drug (IND) application or under the authority of an institutional Radioactive Drug Research Committee (RDRC) may follow either the cGMP regulations in 21 CFR Part 212 or the current United States Pharmacopeia (USP; 32nd edition) General Chapter tided "Radiopharmaceuticals for Positron Emission Tomography-Compounding."
ISSN:	0161-5505 1535-5667