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Baxter Recalls Spectrum Infusion Pumps

[ Price : $8.95]

Baxter Healthcare recalls its Sigma Spectrum Infusion Pumps with Master Drug Library and the Baxter Spectrum IQ Infusion Systems w...

Genentech Gets New Indication for Xolair

[ Price : $8.95]

FDA approves a Genentech supplemental BLA for Xolair (omalizumab) for the add-on maintenance treatment of nasal polyps in adult pa...

Guide on Gastric pH-Dependent Drug Interactions

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Federal Register notice: FDA makes available a draft guidance entitled Evaluation of Gastric pH-Dependent Drug Interactions With A...

Hahn Summoned to White House About Vaccine Delay

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President Trumps chief of staff Mark Meadows summons FDA commissioner Stephen Hahn to the White House 12/1 to learn why the agency...

FDA Recognizes A2LA for ASCA Pilot

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FDA recognizes A2LA to assess testing laboratories for the Accreditation Scheme for Conformity Assessment pilot program.

After FDA Meeting, Minerva Continuing Roluperidone Development

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Minerva Neurosciences says it believes it can address negative FDA comments about two roluperidone studies through published regul...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include ForYou Inc. and Industry Lab Diagnostic Partners.

Comments Extended on Antimicrobial Animal Drugs

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Federal Register notice: FDA extends the comment period for a 10/13 notice announcing a public meeting and requesting comments on ...

Guide on Animal Drug In-use Stability Studies

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Federal Register notice: FDA makes available a final guidance for industry #242 entitled In-Use Stability Studies and Associated L...

Evaluating Gastric pH-Dependent Drug Interaction Guidance

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FDA makes available a draft guidance on Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Desi...