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Former Walter Reed Employee Indicted on False Statements

[ Price : $8.95]

A federal grand injury indicts a former Walter Reed National Military Medical Center employee on charges involving accepting finan...

FDA Draft Biosimilar Licensure Guidance

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FDA issues a draft guidance to help applicants seeking licensure for a proposed biosimilar or interchangeable biosimilar for fewer...

Research on Opioid Abuse Deterrent Formulations

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Federal Register notice: FDA seeks comments on proposed research on Health Care Providers Understanding of Opioid Analgesic Abuse ...

Serological Tests for Transfusion Risks Guide

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Federal Register notice: FDA makes available a final guidance entitled Use of Serological Tests to Reduce the Risk of Transfusion-...

Comments on Patient-Focused Development Guidance

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Stakeholders comment on an FDA guidance and public workshop on patient-focused drug development.

2019 Ropes & Gray FDA Enforcement Review

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Ropes & Gray attorneys review FDA enforcement action in a number of areas in 2019.

Alarmingly High Antibiotic Scripts Not Infection Related

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University researchers say nearly half of antibiotic fills for Medicaid patients do not involve treating an infection.

5 Observations in Dr. Reddys FDA-483

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FDA releases an FDA-483 with five observations from an inspection at a Dr. Reddys API manufacturing facility in Andhra Pradesh, In...

FDA Clears Life Spines Plateau Ti

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FDA clears a Life Spine 510(k) for its Steerable Plateau Ti Spinal System.

Gottlieb Joins Illuminas Board of Directors

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Former FDA commissioner Scott Gottlieb joins Illuminas board of directors.