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Contract Pharma Cited on Environmental Issue

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FDA sends Contract Pharmaceuticals Limited a Form FDA-483 citing one observation after its Mississauga, Canada facility was inspec...

Guide on Bioequivalence Study Data Integrity

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Federal Register notice: FDA makes available a draft guidance entitled Data Integrity for In Vivo Bioavailability and Bioequivalen...

HHS Defines FDA Roles in Drug Shortages

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A new HHS white paper on drug shortage policies cites many steps FDA has taken and wants to take in the future.

Abbott's TriClip OK'd for Tricuspid Regurgitation

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FDA approves Abbotts TriClip, a transcatheter edge-to-edge repair system that is designed for treating tricuspid regurgitation.

FDA Qualifies Lethal Arrhythmia Database

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The FDA Medical Device Development Tool program qualifies the University of California San Francisco Lethal Arrhythmia Database.

FDA OKs Zevtera Antibiotic with 3 Indications

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FDA approves Basilea Pharmaceuticas antibiotic Zevtera for three indications.

Lenz Plans NDA for Presbyopia Eye Drops

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Lenz Therapeutics says it will file an NDA for aceclidine eye drops in a few months after reporting Phase 3 study results for trea...

Prenosis AI Sepsis Predictor Authorized for Use

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FDA grants Prenosis a de novo marketing authorization for its Sepsis ImmunoScore, an artificial intelligence/machine learning soft...

OPQ Supported 55 Novel Drug Approvals in 2023

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The CDER Office of Pharmaceutical Quality outlines its accomplishments in 2023 under four strategic priorities.

More Changes Urged in RRA Revised Guidance Comments

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Several stakeholder organizations say they appreciate that FDA revised its draft guidance on regulatory review assessments and sug...