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...

وصف كامل

محفوظ في:
التفاصيل البيبلوغرافية
المؤلف الرئيسي: Berry, Ira R.
مؤلفون آخرون: Martin, Robert P.
التنسيق: كتاب
اللغة:الإنجليزية
منشور في: New York Informa Healthcare USA Inc. 2021
الطبعة:2nd ed.
سلاسل:Drugs and The Pharmaceutical Sciences Series Vol. 185
الموضوعات:
الوسوم: إضافة وسم
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الوصف
الملخص: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.
وصف مادي:x, 469 p.
ردمك:9780367202842