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...

Täydet tiedot

Tallennettuna:
Bibliografiset tiedot
Päätekijä: Berry, Ira R.
Muut tekijät: Martin, Robert P.
Aineistotyyppi: Kirja
Kieli:englanti
Julkaistu: New York Informa Healthcare USA Inc. 2021
Painos:2nd ed.
Sarja:Drugs and The Pharmaceutical Sciences Series Vol. 185
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Kuvaus
Yhteenveto: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.
Ulkoasu:x, 469 p.
ISBN:9780367202842