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FDA Meeting on Antimicrobial Resistance Monitoring

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Federal Register notice: FDA announces a 10/24-25 public meeting entitled 2017 Scientific Meeting of the National Antimicrobial Re...

Workshop on Pediatric Drug Development for Heart Failure

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Federal Register notice: FDA announces a 10/27 public workshop entitled FDA-University of Maryland CERSI Drug Development in Pedia...

FDA Panel to Review Intraocular Pressure Drug

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Federal Register notice: FDAs Dermatologic and Ophthalmic Drugs Advisory Committee meets 10/13 to review intraocular pressure drug...

FDA OKs 98% of Individual Expanded Access Requests

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Four FDAers analyze the agencys response to individual drug expanded-access requests over a four-year period and find that 98% wer...

5th Circuit Backs Solvay False Claims Case Dismissal

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The 5th Circuit Court of Appeals upholds a Texas federal court ruling granting summary judgment to Solvay Pharmaceuticals in a whi...

Analytical Similarity Statistical Guidance Out

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FDA releases a draft guidance on statistical approaches to evaluating analytical similarity between biosimilars and their referenc...

Safety Alert Issued on Intercepts Ocaliva

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An FDA safety alert warns that Intercept Pharmaceuticals liver disease drug Ocaliva (obeticholic acid) is being incorrectly dosed ...

FDA Clears Brainlab Radiosurgery Planning Software

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FDA clears a Brainlab 510(k) for Elements Spine SRS and Elements Cranial SRS, two software applications that aid in the patient-ta...

Diverse Views on Waxman-Hatch Balance

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Stakeholders offer FDA a variety of perspectives on how well the Waxman-Hatch amendments balance innovation and access.

FDA Backs Use of Opioid Addiction Drugs Despite Risks

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FDA says that opioid addiction medications buprenorphine and methadone should continue to be given to patients taking benzodiazepi...