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FDA NextGen Submission Portal Guide

[ Price : $8.95]

FDA publishes a guide to its Electronic Submission Gateway NextGen Unified Submission Portal.

Public Confidence in FDA, Others Dropping: Survey

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The latest University of Pennsylvania Annenberg Public Policy Center survey documents a significant drop since last fall in the pe...

Lillys Inluriyo OKd for Breast Cancer

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FDA approves an Eli Lilly NDA for Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist for treating certa...

CBER Posts 13 FDA Form-483s

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CBER posts 13 Form FDA-483s under the Freedom of Information Acts provision on frequently requested records.

Biolinq Gets De Novo for Glucose Sensor

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FDA grants Biolinq a de novo authorization for its Shine system, said to be the first fully autonomous, needle-free glucose sensor...

Cellebration Refusing to Provide Records to FDA

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FDA warns San Juan, Puerto Rico-based Cellebration LLC that it is violating the Federal Food, Drug, and Cosmetic Act and agency re...

Acadias Phase 3 Trial of Intranasal Carbetocin Fails

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Acadia Pharmaceuticals says it will cease developing intranasal carbetocin after its Phase 3 COMPASS PWS trial of the drug for tre...

Regenerative Therapies Expedited Programs

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FDA publishes a draft guidance with recommendations for expedited development and review of regenerative medicine therapies for se...

CGT Trial Innovative Designs Guidance

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FDA publishes a draft guidance on agency requirements and considerations for using various clinical trial designs and endpoints to...

Interchangeable Biosimilar Bill Introduced

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Reps. Pfluger and Landsman introduce bipartisan legislation to deem biosimilars to be interchangeable upon FDA approval.