The Pharmaceutical Regulatory Process
Redigert av Ira R. Berry, Robert P. Martin, 2008.Del av serien Drugs and the Pharmaceutical Sciences.
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.
New chapters cover:
- the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance
- pharmacovigilance programs designed to prevent widespread safety issues
- legal issues surrounding the sourcing of foreign APIs
- the issues of counterfeit drugs
- updates on quality standards
Språk: Engelsk
Ikke tilgjengelig for Klikk&Hent
Midlertidig tomt på lager
Bestillingsvare. Forventes sendt om ca 10 dager
The Pharmaceutical Regulatory Process
Redigert av Ira R. Berry, Robert P. Martin, 2008.Del av serien Drugs and the Pharmaceutical Sciences.
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.
New chapters cover:
- the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance
- pharmacovigilance programs designed to prevent widespread safety issues
- legal issues surrounding the sourcing of foreign APIs
- the issues of counterfeit drugs
- updates on quality standards
Språk: Engelsk
Ikke tilgjengelig for Klikk&Hent
Midlertidig tomt på lager
Bestillingsvare. Forventes sendt om ca 10 dager
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