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Info on Clinical Laboratory Improvement Amendments

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on requests for c...

Comments Sought on HCT/P Regulations

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Federal Register Notice: FDA seeks comments on the information collection requirements for regulations on human cells, tissues, an...

FDA Issues Emergency Use Authorization for Zika Diagnostic

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Federal Register Notice: FDA issues an Emergency Use Authorization for an in vitro diagnostic device for detecting Zika virus.

FDA Priority Review for Mercks Keytruda in Lung Cancer

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FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for first-line treatme...

Florida Court Backs Apotex in Biosimilar Patent Case

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The Southern Florida District Court rules that Apotexs proposed filgrastim and pegfilgrastim biosimilar products will not infringe...

FDA Infectious Disease Designation for Taxis Pharmas TXA709

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FDA grants Taxis Pharmaceuticals a qualified infectious disease product designation for TXA709, which targets acute bacterial skin...

Comments Sought on Vinpocetine

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Federal Register Notice: FDA requests comments on the regulatory status of vinpocetine.

Bausch & Lomb Inspection FDA-483 Out

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FDA releases an FDA-483 from a Bausch & Lomb inspection in Tampa, FL, last February.

Data Integity, CGMP Issues at Zhejiang Hisoar

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FDA warns Chinas Zhejiang Hisoar Pharmaceutical Co. about CGMP and data integrity concerns in manufacturing active pharmaceutical ...

Judge Allows 3 Liability Claims Against Invokana

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Ruling against federal preemption, a Louisiana federal court allows three state law product liability claims against Janssens Invo...