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New FDA User Fee Bill Contains Rider ‎That Would Permanently Alter FDA’s Regulation ‎of Cosmetics

On May 26, Senators Murray and Burr introduced S. 4348 (pg. 97). The primary focus of the bill was to pass reauthorizations of FDA’s critical user fee programs for drugs, medical devices and biologics, which are scheduled to...more

FDA Issues Guidance Detailing Current Policies on Facility Inspections and Product Approvals During the COVID-19 Pandemic

The COVID-19 pandemic presents ongoing challenges to the pharmaceutical and biologics industries, where in-person inspection of facilities is often required for FDA approval of applications to market drug or biological...more

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