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FDA Monitoring Drug Shortages After Pfizer Tornado

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FDA says it is working with Pfizer to monitor the potential for drug shortages after a 7/19 tornado severely damaged Pfizers large...

Info Collection on Blood Product GMPs

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Federal Register notice: FDA sends to OMB an information collection revision entitled Current Good Manufacturing Practice for Bloo...

FDA Announces 7 Info Collections Approved

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Federal Register notice: FDA announces that seven information collections have been approved by OMB.

Astria Gets Fast Track for Angioedema Drug

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FDA grants Astria Therapeutics fast track status for STAR-0215 for treating hereditary angioedema.

FDA OKs Vanflyta for Leukemia

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FDA approves a Daiichi Sankyo NDA for Vanflyta (quizartinib) in certain patients with newly diagnosed acute myeloid leukemia.

New FDA Tools in Democrats Preparedness Bill

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All Democrats on the House Energy and Commerce Committee sponsor legislation to reauthorize the Pandemic and All-Hazards Preparedn...

Dont Use Quidel Triage Cardiac Panel: FDA

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FDA says healthcare providers, laboratories, and facilities should immediately stop using the Quidel Triage Cardiac Panel due to i...

Ex-FDA Gene Therapy Guru Joins Greenleaf

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Former CBER Office of Tissues and Advanced Therapies director Wilson Bryan joins regulatory consulting firm Greenleaf Health as e...

8 Repeat QS Violations at Edge Biologicals

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FDA warns Memphis, TN-based Edge Biologicals about eight repeated Quality System violations in its manufacturing of in vitro diagn...

Ambrx Gets Fast Track for Prostate Cancer Drug

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FDA grants Ambrx Biopharma a fast track designation for ARX517 for treating certain patients with metastatic castration-resistant ...