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Local Anesthetic Drug Guidance

[ Price : $8.95]

FDA publishes a draft guidance with information for sponsors who are developing certain local anesthetic drug products to produce ...

PhRMA Comments on Drug Labeling Guidance

[ Price : $8.95]

PhRMA suggests changes to an FDA revised draft guidance on the content and format of the Dosing and Administration section of drug...

Janssen Vaccine Warning on Myocarditis/Pericarditis

[ Price : $8.95]

FDA revises the fact sheets on Janssens Covid-19 vaccine to include a warning about reported adverse events that suggest increased...

FDA Clears Telehealth Respiratory Wheeze Detector

[ Price : $8.95]

FDA clears a TytoCare 510(k) for its Tyto Insights for Wheeze Detection, an algorithm for use on the companys existing artificial ...

CGMP Violations at Formology Lab

[ Price : $8.95]

FDA warns Chatsworth, CA-based Formology Lab about CGMP violations in its production of drugs as a contract manufacturer.

Objectionable Conditions at Avanti Study Site: FDA

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FDA warns Houston, TX- based Dr. Maggie Jeffries/Avanti Anesthesiology about conducting a clinical investigation without a require...

Guide on Gastric pH-Dependent Drug Interactions

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance for industry entitled Evaluation of Gastric pH-Dependent Drug Intera...

FDA Revokes 2 EUAs for Covid Tests

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Federal Register notice: FDA revokes the Emergency Use Authorizations for Covid-issued to Abbott Diagnostics and Standard BioTools...

FDA Authorizes Pfizer Bivalent Vaccine for Young Children

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FDA amends the emergency use authorization for the Pfizer-BioNTech Covid-19 bivalent vaccine and its use as a single booster dose ...

Profounda Significant CGMP Violations

[ Price : $8.95]

FDA warns Orlando, FL-based Profounda about CGMP violations in its production of finished drugs as a contract manufacturer.