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Pneumonia Drug Development Guidances

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FDA issues guidances to help sponsors develop drugs intended to treat three types of bacterial pneumonia.

Home Care Pharmacy Compounding Violations

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FDA says Home Care Pharmacy of Palm Coast violated regulations involving compounded drug products and adulterated drugs.

preCardia Gains Breakthrough Status for ADHF Device

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FDA grants preCardia, Inc., a breakthrough device designation for its catheter-based system for treating volume overload in patien...

Covid Antibody Tests Not Definitive: FDA

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FDA says healthcare providers should continue to use coronavirus antibody tests to help identify people who have been exposed to t...

FDA Lifts Partial Hold on Lymphoma Trial

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FDA lifts a partial clinical hold against an Innate Pharma Phase 2 clinical trial (TELLOMAK) that is evaluating the efficacy and s...

CBER Updates List of Proposed Guidances

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CBER updates its list of guidance documents it plans to issue in 2020, noting that 16 of the 28 earlier proposed documents have al...

INSPIRE Questionnaires OKd as Development Tools

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FDA says it has qualified INSPIRE questionnaires through the medical device development tool program to assess the impact of autom...

Public Citizen Asks Diabetes Drug Boxed Warning

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Public Citizen asks FDA for a Boxed Warning and other labeling changes for several drugs approved for Type 2 diabetes to indicate ...

Mayne NDA Accepted for Novel Contraceptive

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FDA accepts for review a Mayne Pharma Group NDA for E4/DRSP (estetrol and drospirenone) for preventing pregnancy.

FDA Withdraws 12 No Longer-Marketed ANDAs

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Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants because they are no longer being marketed.