Tag Archives: Margaret Hamburg

US Regulators and Industry Bodies Push Forward with Global Expansion

At the annual meeting of the Food and Drug Law Institute (FDLI) this year, FDA commissioner Margaret Hamburg concluded her keynote address by describing a “dramatically changing global marketplace” and its “huge implications” for FDA’s ability to ensure the safety and quality of products manufactured elsewhere. In addition to conducting more inspections and oversight of […]
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New Fees Made FDA Worse for Generic Drug Approvals, Says GPhA Chairman

‘Actions’ don’t speak louder than words in dealing with FDA’s backlog of generic drug applications, says newly-elected GPhA Board Chairman Craig Wheeler. When the Generic Drug User Fee Act (GDUFA) was signed into law on July 7, 2012, its primary intent was to provide FDA with the additional resources necessary to expedite the review process […]
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Provider Demand to Drive Compounder Registration with FDA

The Food and Drug Administration is moving fast to implement the drug compounding provisions of new Drug Quality and Security Act (DQSA), issuing new guidance to spur registration by outsourcing facilities just days after President Obama signed the new bill into law. But because FDA cannot compel compounders to opt for agency regulation, implementation will […]
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There's New Hustle in Myeloma

The Multiple Myeloma Research Foundation (MMRF) has launched a new initiative to increase the pace of innovation in myeloma research through faster cures and more efficient, timely trials for patients. Founded in 1998, MMRF is the leading non-profit organization in the myeloma space, dedicating 90 per cent of its funding to medical research, disease awareness […]
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FDA, CDER Weigh Organizational Changes

FDA commissioner Margaret Hamburg has formed a top-level working group to propose strategies for enhancing agency functions and processes, starting with the relationship between FDA Centers and its field force. The Program Alignment Group (PAG), announced Sept. 6, 2013, will seek to clarify the roles and responsibilities of product centers and the Office of Regulatory […]
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