FDA warns about fraudulent COVID-19 test kits for home use

The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.

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FDA kicks off pilot program for recognizing qualified accreditation bodies who would accredit testing laboratories

The U.S. Food and Drug Administration issued a draft guidance Friday outlining the goals and implementation of a new voluntary conformity assessment initiative, the Accreditation Scheme for Conformity Assessment (ASCA) Pilot, designed to promote consistency and predictability in the premarket review process for medical devices, encourage effective use of FDA resources, and enhance regulatory efficiency, while also enhancing confidence in medical device testing.

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FDA approves Teva’s Sabril generic version; says making generic drugs competitive is key part to reduce drug cost

Announcing the approval of Teva’s Sabril generic tablets, FDA Commissioner, Scott Gottlieb said that prioritizing the approval of generic drugs to compete with medicines that face little or no competition is the Agency’s key part of efforts to support access and reduce drug costs to patients.

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