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HHS Good Guidance Rules Could Ossify FDA: Analysis

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Attorney T. Daniel Logan analyzes the impact on FDA of HHS regulations on good guidance practices.

Former Commissioners Support FDA on Vaccines

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

GE Imaging Machines Can Be Hacked: Report

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

Investigate FDA Role with Biogen on Alzheimers Drug: Public Citizen

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

Comments on Renal Function Study Draft Guidance

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Stakeholders suggest revisions to an FDA draft guidance on pharmacokinetics in patients with impaired renal function.

Stakeholders Comment on Breast Cancer Draft Guidance

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Stakeholders support an FDA recommendation to include premenopausal women in breast cancer drug development programs.

FDA to Warn About Severe Reactions with Covid Vaccine: Marks

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CBER director Peter Marks says FDA plans to warn patients whove had previous severe reactions after being vaccinated about such ri...

Natures Boost Selling Unapproved New Drugs: FDA

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

FDA Says Valentus Marketing Several Unapproved New Drugs

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

Guide on Combo Product Feedback Meetings

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