On September 15 2008, FDA’s final rule on “Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials” will become effective.
The Rule makes “early phase 1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (cGMP) statutes and FDA investigational requirements.” Additional detail is available in the FDA’s Companion Guidance Document.
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About axendia
Axendia is a leading consulting and strategic advisory firm focused on the Life-Sciences and Healthcare markets.
Our Mission is to be the most trusted advisor to Life-Science Executives on Business, Regulatory and Technology issues.
We serve the complete Life-Science Eco-System including Life-Science Organizations, Technology & Service Providers and the Investment community.
Axendia professionals offer a unique combination of hands-on experience coupled with strategic vision. Our consultants have an average of 20 years Life-Science experience working with organizations ranging from startups to Fortune 100.
We contribute to our client’s success by helping them navigate the ever changing Business, Technological and Regulatory landscape in the Life-Sciences industry.
Let Axendia provide you the insight you need to make the right decisions in this complex and highly regulated Industry.