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...

תיאור מלא

שמור ב:
מידע ביבליוגרפי
מחברים אחרים: Berry, Ira R., Martin, Robert P.
פורמט: ספר
שפה:אנגלית
יצא לאור: New York Informa Healthcare USA Inc. 2021
מהדורה:2nd ed.
סדרה:Drugs and The Pharmaceutical Sciences Series Vol. 185
נושאים:
תגים: הוספת תג
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תיאור
סיכום: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.
תיאור פיזי:x, 469 p.
ISBN:9780367202842