Simplifying Global Compliance
We partnered with David Smith of Pepper Hamilton for analysis of the FDA’s current inspection/enforcement actions. David—expert in HCT/P donor eligibility & tissue ownership—details how HCT/P establishments can self-audit & assure they will not be in the FDA’s cross-hairs.
Whether you need to help your company convince the FDA to accept a predicate device in a simple 510(k) filing or you’re responsible for implementing UDI across a family of high-risk implantable devices, there’s one thing all regulatory professionals need. The most up-to-date, latest FDA regulations are available in this best-seller.
Is your informed consent process effective and compliant with FDA and OHRP? If you hesitated for even a moment, kindly accept this invitation to preview — at no risk — the 2015 edition of … Informed Consent for Clinical Trials: A Regulatory Reference Guide.
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