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Waxman-Hatch at Risk: Analysis

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Attorney Kurt Karst says Congress is considering drug pricing legislation that is opposed by the Association for Accessible Medici...

BIO Blasts USMCA Provision

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BIO president Jim Greenwood says the administration and House Democrats have surrendered a powerful tool to protect American biote...

Senators Want Action on Hearing Aid Regs

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Sens. Grassley and Warren ask FDA when draft OTC hearing aid regulations will be published

Verax Asks FDA Not to Take Arbitrary Action

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Verax Biomedical calls on FDA not to take actions that would be considered arbitrary and capricious if unsupported by additional s...

Regenerative Therapies Outcome Measures Needed: Report

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The Alliance for Cell Therapy Now calls on FDA and other agencies to act to measure outcomes related to regenerative cell therapie...

Impurity Concerns Spread to Metformin Generics

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FDA says that ongoing concerns about the presence of genotoxic impurities (nitrosamines) in angiotensin II receptor blockers and r...

Magnetic Resonance Coil Performance Criteria Guide

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Federal Register notice: FDA releases a draft guidance on Magnetic Resonance (MR) Coil Performance Criteria for Safety and Perfor...

House Bill Introduced to Lower Drug Costs

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Republican House lawmakers introduce the Lower Costs, More Cures Act (H.R. 19) to lower drug costs for Americans without limiting ...

Equillium Gets Fast Track for Itolizumab

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FDA grants Equillium a fast track designation for itolizumab for treating lupus nephritis.

Draft Guidance Hemorrhoid Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Development of Locally Applied Corticosteroid Products for ...