AG/FDA Blog

Device Firms: What You Should Know About The 21st Century Cures Act

Last month, legislation that would affect, among other things, FDA’s regulation of medical devices and the manufacturers of such devices took a considerable step forward when it was introduced and then unanimously approved by the House Energy and C… Read More
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FDA’s Draft Guidance On DSCSA Preemption Misses The Mark

In a flurry of end-of-year activity, FDA recently issued a Draft Guidance on the express preemption provisions in §585 of the FDC Act, added last year by the Drug Supply Chain Security Act (or DSCSA). FDA, the pharmaceutical supply chain, and other… Read More
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GMO Hearing

Yesterday, the House Energy and Commerce Subcommittee on Health held a hearing to examine FDA’s role in the regulation of genetically engineered foods (commonly, but inaccurately, referred to as “genetically modified organisms” or “GMOs”).… Read More
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Anticipating Committee Changes in the 114th Congress

Every new Congress brings changes in committee membership and sometimes in committee leadership.  The 114th Congress will follow this pattern, and will bring very significant changes as a result of the new Republican majority in the Senate.   Repu… Read More
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