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LDT Oversight Legislation Needed: Pew Research

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The Pew Charitable Trusts say Congress should give FDA authority to regulate some higher-risk laboratory-developed tests.

Panel Backs Pfizer Vaccine in Younger Kids

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FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend the agency authorize the use of Pfizers Covid-...

OMB Info Collection on Drug Registration

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Federal Register notice: FDA sends to OMB an information collection revision entitled Registration of Producers of Drugs and Listi...

Eyenovia Complete Response Related to Genus Decision

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Eyenovia receives a complete response letter on its NDA for MydCombi (tropicamide and phenylephrine), indicated for in-office pupi...

Alkermes Gets Fast Track on Ovarian Cancer Therapy

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FDA grants Alkermes a fast track designation for nemvaleukin alfa, an engineered interleukin-2 variant immunotherapy for use in co...

Advisory Committee to Hear Avenue Dispute Resolution

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CDERs Office of New Drugs says an advisory committee meeting will be convened to review an Avenue Therapeutics dispute resolution ...

Panel to Vote on Ischemic Stroke System

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Federal Register notice: FDA announces a 12/10 meeting of the Medical Devices Advisory Committees Neurological Devices Panel that ...

Biocon Malaysian Plant Gets 6-item FDA-483

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FDA posts a six-observation Form FDA-483 after inspecting a Biocon drug substance manufacturing facility in Malaysia.

FDA Information Page on Endometrial Ablation

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CDRH creates a patient resource Web page to provide information about endometrial ablation for heavy menstrual bleeding.

Guide on Submitting Real-world Data

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Federal Register notice: FDA makes available a draft guidance entitled Data Standards for Drug and Biological Product Submissions ...