Proposed and Final FDA Rules: What’s Left in 2017

Posted 08 August 2017 By Zachary Brennan

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The US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017, according to an updated list of Department of Health and Human Services rulemakings.

Proposed Rulemakings

Among the proposals coming are rulemakings dedicated to pediatric study plan requirements, internal decision making and supervisory review at FDA’s Center for Devices and Radiological Health, the withdrawal of a regulation that any drugs sterilized by irradiation would be considered a new drug, one on biologics license applications and master files and one on decreasing de novo classification burdens for device manufacturers.

Final Rulemakings

Among the final rulemakings are those dedicated to updating FDA’s requirements for accepting clinical data used to bring new medical devices to market, to remove requirements to submit multiple paper copies of medical device regulatory pre-submissions and submissions and replace them with one copy in an electronic format, one to remove mandatory inspection requirements for biologics and replace them with a risk-based approach and one to allow an Institutional Review Board to waive informed consent under certain conditions for minimal risk clinical investigations.

Notably absent on the list for final rulemakings is one related to generic drug labels.

Scott Gottlieb, prior to being named FDA commissioner, told Focus in May 2016 on the proposed rule for generic labels: “FDA needs to bear more responsibility for updating the labels of old generic drugs and can take on that role, rather than foisting it onto generic drug makers in a way that will not only increase generic costs and expose them to the same sort of failure to warn suits that plague branded companies, but will undermine the generic model by creating incongruities between the labelling of the same generic drug, solely by virtue of the manufacturer and what CBE [changes-being-effected] supplements they happened to file. I think this is the most inefficient way to achieve what FDA purports to be their public health goal here, which is why I believe this was politically contrived, or at least politically influenced.”

Agency Rule List - Update 2017

 

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: FDA rulemakings, biologics manufacturing inspections, de novo, medical device rulemakings

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