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Guide on Cancer Trial Placebo Use & Blinding

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Federal Register notice: FDA releases a final guidance on using placebos and allowing blinding in cancer clinical trials.

AstraZeneca Study Meets Endpoint with Lupus Drug

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AstraZeneca says that the Phase 3 TULIP 2 trial for anifrolumab, an investigational drug for treating systemic lupus erythematosus...

Support, Criticism for Opioid Benefit/Risk Framework Guidance

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Stakeholders praise and criticize an FDA draft guidance on a benefit/risk assessment framewok for opioids.

FDA Seeks Move to New Duodenoscopes

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An FDA safety alert recommends that healthcare providers transition to duodenoscopes with innovative designs that are more safe an...

2 Medical Device Benefit/Risk Guidances

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FDA issues two final guidances explaining its views on making benefit/risk determinations for certain medical device approval appl...

8 Observations on Dr. Reddys FDA-483

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FDA issues an FDA-483 with eight observations from an inspection at Dr. Reddys drug manufacturing facility in Andhra, Pradesh, Ind...

Tourettes Drug Gains Fast Track Status

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FDA grants Emalex Biosciences a fast track designation for its investigational drug ecopipam for treating patients with Tourette S...

Final Guide on Placebos/Blinding in Cancer Trials

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FDA releases a final guidance on use of placebos and blinding in cancer clinical trials.

Viela Bio BLA for Rare Autoimmune Disorder

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FDA accepts for review a Viela Bio BLA for inebilizumab, an investigational anti-CD19 monoclonal antibody for treating patients wi...

Safety Alert on Hep C Protease Inhibitors

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FDA issues a safety alert on three chronic hepatitis drugs after some patients with moderate to severe liver impairment experience...