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A Federal Register notice, published on May 31, announced FDA’s intention to cooperate with the World Health Organization (WHO) in order to strengthen regulatory capacity, support product development, and foster the development of meaningful norms and standards. Particular goals cited are: ● building the knowledge base of the current state of regulatory oversight of bi- ological products ● providing technical support for strengthening efforts of regulatory systems ● assisting WHO member states in the implementation of international quality standards, and ● assisting in developing and increasing access to biologics.
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