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Tricida Surprised at FDA Veverimer Comments

[ Price : $8.95]

Tricida says it is surprised that FDA does not believe its veverimer development program provides sufficient evidence for accelera...

FDA Using Emulate to Evaluate Covid Vaccine Safety

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FDA continues a research agreement with Emulate to use its organ-chips in studies of Covid-19 vaccines.

Medical Device Nitinol Increases Bench Testing: Analysis

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Attorney Michael Kasser says requirements in a new FDA guidance could mean that medical device companies should avoid using nitino...

Better Understanding of Heterogeneous Treatment Effects

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Panelists from FDA, universities, and private companies look at ways to better understand the heterogeneous treatment effects of d...

Biosimilar User Fee Reauthorization Meeting

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Federal Register notice: FDA announces an 11/19 virtual public meeting on reauthorizing the Biosimilar User Fee Act program.

Guidance on Nonclinical Testing for Nicotine Products

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Federal Register notice: FDA makes available a final guidance on inhaled nicotine product nonclinical testing.

Cleaning Method Deviations Could Impair Sigma Pump: Baxter

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FDA says Baxter is reminding customers that deviations from prescribed cleaning methods for Sigma Spectrum infusion pumps could hu...

Timely PSGs Can Spur ANDA Submissions: CDER Research

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CDER analyzes factors that contribute to an increased likelihood of ANDA submissions for NCE and non-NCE innovator drugs.

FDA Enhancements Sought for Model-Informed Drug Development

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FDA pitches a plan to enhance its Model-Informed Drug Development (MIDD) activities under the next iteration of its Prescription D...

FDA Inks Agreement with SomaLogic for Proteomics Study

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FDA signs a five-year agreement with SomaLogic to study using proteomics to identify biomarkers that may be useful in demonstratin...