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FDA General

Principal Deputy Commissioner Abernethy Leaving FDA

FDA principal deputy commissioner and acting chief information officer Amy Abernethy announces she will be leaving the agency in the next few weeks.

Medical Devices

Recovery Force Leg Mover/Compressions Device Cleared

FDA clears a Recovery Force 510(k) for the Movement and Compressions System, a data-driven mobility measurement device designed for hospital and home ...

Human Drugs

Cybrexa Therapeutics to Begin Cancer Trial of CBX-12

FDA gives Cybrexa Therapeutics the green light to begin a clinical trial for solid tumor therapy CBX-12 (alphalex-exatecan).

Human Drugs

Pfizer Arthritis Drug Has Small Efficacy, Safety Concerns: FDA

An FDA advisory committee briefing document says a Pfizer BLA for osteoarthritis drug tanezumab subcutaneous injection shows (XXX SUBSTITUTE XXX) a mo...

Biologics

AstraZeneca Covid Vaccine has 79% Efficacy

AstraZeneca interim data show that its Covid-19 vaccine efficacy 79% at preventing symptomatic Covid-19 and 100% efficacy at preventing severe disease...

Human Drugs

FDA Warns Firms Illegally Selling CBD Products

FDA sends Warning Letters to two companies for selling OTC products labeled as containing cannabidiol.

Human Drugs

Gonorrhea Drug Development Public Workshop

FDA announcess 4/23 virtual public workshop entitled Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.

Medical Devices

First Machine-learning Covid Screening Device Authorized

FDA grants Tiger Tech Solutions an emergency use authorization for the first machine learning-based Covid-19 non-diagnostic screening device that iden...

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notice for the week ending 3/19/2021.

Medical Devices

Meeting on Device Patient-generated Data

FDA announces a 5/4 virtual public meeting entitled Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices.