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Final Guide on Drug Proprietary Names

[ Price : $8.95]

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

Guide on Drug Proprietary Names Best Practices

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Federal Register notice: FDA makes available a draft guidance entitled Best Practices in Developing Proprietary Names for Human No...

Pfizer BLA Accepted for Pneumococcal Conjugate Vaccine

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FDA accepts for priority review a Pfizer BLA for its 20-valent pneumococcal conjugate vaccine and its us for preventing invasive d...

SoniVie Breakthrough Status for Hypertension Device

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FDA grants SoniVie a breakthrough device designation for the Tivus System for renal artery denervation and its use in treating res...

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Comments on Renal Function Study Draft Guidance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Stakeholders suggest revisions to an FDA draft guidance on pharmacokinetics in patients with impaired renal function.

Stakeholders Comment on Breast Cancer Draft Guidance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.