The Pharmaceutical Regulatory Process

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 to...

Deskribapen osoa

Gorde:
Xehetasun bibliografikoak
Beste egile batzuk: Berry, Ira R., Martin, Robert P.
Formatua: Liburua
Hizkuntza:ingelesa
Argitaratua: New York Informa Healthcare USA Inc. 2021
Edizioa:2nd ed.
Saila:Drugs and The Pharmaceutical Sciences Series Vol. 185
Gaiak:
Etiketak: Etiketa erantsi
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Deskribapena
Gaia: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.
Deskribapen fisikoa:x, 469 p.
ISBN:9780367202842