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
General
Is the information for this product incomplete, wrong or inappropriate?
Let us know about it.
Does this product have an incorrect or missing image?
Send us a new image.
Is this product missing categories?
Add more categories.
Review This Product
No reviews yet - be the first to create one!