Recent Articles

FDA Issues Guidance on STeP

Earlier this year, the United States Food and Drug Administration (FDA) finalized guidance for devices and combination products, Safer Technologies Program (STeP) for Medical Devices. The new guidance…

Review of 2020 FDA Enforcement Activities

Recently, the attorneys at Ropes & Gray wrote an article reviewing the United States Food and Drug Administration’s (FDA) 2020 enforcement priorities, including protecting patients from those who…

FDA Releases Final Guidance Under GDUFA II

In mid-December 2020, the United States Food and Drug Administration finalized updated guidance to generic drug manufacturers. The final guidance updates a 2017 draft, Controlled Correspondence…
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