Confronting perils, fostering innovation with 21 CFR part 11

Confronting perils, fostering innovation with 21 CFR part 11

MA: You would think so, but honestly, in many cases there's not a lot of scrutiny placed on the preliminary, initial data because of the things I just discussed. The fact is, as it gets closer and closer to submission [and putting it into clinical trials], the companies actually step up their o...

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Veröffentlicht in:Drug Discovery & Development 2003-05, Vol.6 (5), p.30
Hauptverfasser: Keating, Sean, Ambrose, Michael J
Format: Artikel
Sprache:eng
Schlagworte:
Ambrose, Michael J
Clinical trials
Compliance
Electronic documents
FDA approval
Federal regulation
Pharmaceutical industry
Regulation
Risk assessment
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Zusammenfassung:MA: You would think so, but honestly, in many cases there's not a lot of scrutiny placed on the preliminary, initial data because of the things I just discussed. The fact is, as it gets closer and closer to submission [and putting it into clinical trials], the companies actually step up their own controls because they know that they are investing a lot of money now, and the FDA may look at that data. In essence, the majority of the data that the FDA looks at is after [a drug is] into clinical trials.
ISSN:1524-783X
1558-6022