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Pharmacometric Models in Drug Development: FDA

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FDA says it supports increasing use of pharmacometric models in drug development because they allow a better understanding of drug...

Covid-19 Guidance Documents Listing

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Federal Register notice: FDA updates the availability of guidance documents related to the Covid-19 public health emergency.

Hospiras Sodium Chloride Ripe for ANDAs: FDA

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Federal Register notice: FDA determines that Hospiras sodium chloride 14.6% solution for injection (50 milliequivalent/20 millilit...

De Novo Granted for Stroke Rehab Device

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FDA grants a de novo marketing authorization for Neurolutions IpsiHand Upper Extremity Rehabilitation System for use in adult pati...

Cordis Class 1 Recall of Precise Carotid System

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Cordis recalls (Class 1) its Precise PRO Rx Carotid System because of the potential for the distal tip to become separated from th...

ICH Revised Guideline on Residual Solvents

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The International Conference for Harmonization posts for adoption a revised guideline entitled ICH Q3C(R8) Guideline on Impurities...

FDA Approves Roche Diagnostic for GSKs Jemperil

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FDA approves a Roche PMA for its Ventana MMR RxDx Panel, a companion diagnostic for qualifying patients for treatment with GlaxoSm...

FTC Seeks Restored Disgorgement Authority

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The FTC says it will urge Congress to quickly and advance legislation to strengthen its powers in the wake of a Supreme Court deci...

CDC Panel Recommends Resumption of J&J Vacine

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A CDC advisory committee recommends that the U.S. resume vaccinations with Johnson & Johnsons Covid-19 vaccine.

Texas Bill Could Expand Off-Label Drug Use

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A Texas state senator introduces legislation to facilitate manufacturer sharing of information on off-label uses for drugs.