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Biologics

Former Commissioners Support FDA on Vaccines

Three former FDA commissioners praise the agencys work to date in Covid-19 vaccine development in a politically charged environment.

Medical Devices

GE Imaging Machines Can Be Hacked: Report

CyberMDX says that GE imaging systems have a cyber vulnerability that could put system operation and patient data at risk.

Human Drugs

Investigate FDA Role with Biogen on Alzheimers Drug: Public Citizen

Public Citizen says the HHS Inspector General should probe FDA collaboration with Biogen to salvage the Alzheimers drug aducanumab.

Human Drugs

Comments on Renal Function Study Draft Guidance

Stakeholders suggest revisions to an FDA draft guidance on pharmacokinetics in patients with impaired renal function.

Human Drugs

FDA Expands Partnership with Palantir Technologies

FDA expands its partnership with Palantir Technologies through a new $44.4 million three-year contract.

Federal Register

Final Guide on Drug Proprietary Names

Federal Register notice: FDA releases a final guidance entitled Best Practices in Developing Proprietary Names for Human Prescription Drug Products.

Federal Register

Guide on Drug Proprietary Names Best Practices

Federal Register notice: FDA makes available a draft guidance entitled Best Practices in Developing Proprietary Names for Human Nonprescription Drug P...

Human Drugs

Natures Boost Selling Unapproved New Drugs: FDA

FDA warns Natures Boost that it is marketing misbranded unapproved new drugs.

Human Drugs

FDA Says Valentus Marketing Several Unapproved New Drugs

FDA warns Valentus, Inc., that it is taking orders for misbranded unapproved new drugs.

Medical Devices

Guide on Combo Product Feedback Meetings

FDA posts a final guidance on Requesting FDA Feedback on Combination Products.