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QS Issues at DFI Company

[ Price : $8.95]

FDA warns Koreas DFI Co., Ltd. about Quality System and Medical Device Reporting violations in its manufacturing of reagent strips...

Pay Attention to FDA AI Reviews: Attorneys

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Three Morgan Lewis attorneys tell regulated product sponsors to watch for AI involvement in FDA reviews and be prepared to respond...

Makary Pledges Mifepristone Study

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FDA commissioner Martin Makary says agency scientists will review the safety of the abortion drug mifepristone based on findings f...

Makary Struggles to Clarify New Covid Recommendations

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FDA commissioner Marty Makary appears to struggle to convey the governments Covid-19 vaccine recommendations in a contentious inte...

Rechon Life Sciences Violations

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FDA warns Swedens Rechon Life Sciences about CGMP violations in its production of finished drugs.

CGMP Violations at Zhejiang Easyclean

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FDA warns Chinas Zhejiang Easyclean Daily Chemical Co. about CGMP violations in its production of finished drugs.

FDA Drops LDT Regulation, Looks to RUOs: Attorneys

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Two Hyman, Phelps & McNamara attorneys say FDA may give research-use-only products greater regulatory scrutiny as a way to maintai...

CBERs Prasad Outlines Rare Disease Goals

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CBER director Vinay Prasad outlines his expectations for advancing rare disease products, such as embracing both surrogate endpoin...

Nubega OKd as Single Agent in Prostate Cancer

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FDA approves a Bayer Healthcare Pharmaceuticals supplemental NDA for Nubega (darolutamide) for metastatic castration-sensitive pro...

NDA Filed for Kuras Ziftomenib for Rare Leukemia

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FDA accepts for priority review a Kura Oncology NDA for ziftomenib, a potential new treatment for certain adult patients with rela...