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FDA Warns on Homeopathic Teething Products

[ Price : $8.95]

FDA warns that homeopathic teething tablets and gels may pose a risk to infants and children.

SEC Charges Ex-Puma Executive on Insider Trading

[ Price : $8.95]

The Securities and Exchange Commission charges the former senior director of regulatory affairs for Puma Biotechnology with inside...

FDA Sets Tropical Disease Voucher Fee at $2.7 Million

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Federal Register Notice: FDA announces the fee rate of $2.7 million for using a tropical disease priority review voucher for fisca...

Rare Pediatric Disease Priority Voucher Fee is $2.7 Million

[ Price : $8.95]

Federal Register Notice: FDA announces the fee rate of $2.7 million for using a rare pediatric disease priority review voucher for...

FDA Posts ICH Guidance on API GMPs

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FDA releases an International Conference on Harmonization guidance on Q7 Good Manufacturing Practice Guidance for Active Pharmaceu...

FDA Gives Breakthrough Status to AbbVie Hep C Therapy

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FDA grants AbbVie a breakthrough therapy designation for its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibre...

FDA Clears NuVasives MAGEC Spinal Implant

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FDA clears a NuVasive 510(k) for its MAGEC system to be surgically implanted using its Reline posterior fixation system for treati...

FDA OKs Label Extension for Tagrisso Companion Diagnostic

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FDA approves a label extension for Roches EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Ze...

Court Allowing FDA to Regulate Medical Practice: Attorneys

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Attorneys Anne Walsh and Andrew Hull says a recent 9th Circuit appeals court decision gives FDA an opportunity to regulate the pra...

FDA Clinical Hold on Alcobra ADHD Trial

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FDA places a clinical hold on an Alcobra Ltd. clinical trial called MEASURE that is evaluating its investigational drug metadoxine...