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Human Drugs

FDA Warns CBD Web Site Over Covid-19 Claims

FDA cites Living Senior, Las Vegas, NV, over its www.blueribbonhemp.com Web site that markets CBD products for treating Covid-19 patients.

Federal Register

Device Panel to Review TransMedics Donor Heart Care System

Federal Register notice: FDA announces a 10/7 meeting of its Medical Devices Advisory Committees Circulatory System Devices Panel, which will discuss ...

Human Drugs

Bayshore Recalls 2 Lots of Metformin

Bayshore Pharmaceuticals recall two lots of metformin hydrochloride extended-release tablets due to the detection of N-nitrosodimethylamine levels abo...

Federal Register

Info Collection Extension on Focus Groups

Federal Register notice: FDA sends to OMB an information collection extension on Focus Groups as Used by the Food and Drug Administration (All FDA-Reg...

Federal Register

Outsourcing Facility Registration Information Collection

Federal Register notice: FDA seeks comments on a revised information collection on Registration of Human Drug Compounding Outsourcing Facilities and A...

Federal Register

Info Collection on Device Corrections and Removals

Federal Register notice: FDA sends to OMB an information collection on medical device corrections and removals reporting.

Medical Devices

Trump Lifts Lab Tests from Need to Get OK from FDA

A new Trump Administration initiative exempts laboratory-developed tests, including those for Covid-19, from the need to get FDA premarket review.

Hahn Reassures Public in TV Appearance

FDA commissioner Stephen Hahn tells a Michigan TV station that the agency is not under any political pressure to speed approval of a Covid-19 vaccine....

Medical Devices

FDA Multifunctional Device Guidance Explained

Ropes & Gray attorneys outline key provisions in an FDA final guidance on multiple function medical devices.

Marketing

False or Misleading Claims, Representations in Gvoke Ad

The CDER Office of Prescription Drug Promotion says a TV ad for Xeris Gvoke fails to provide important risk information but misrepresents the products...