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Biosimilar Formal Meetings Draft Guide

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FDA posts a draft guidance on biosimilar development formal meetings between the agency and sponsors.

PhRMA, Others Boost FDA Discussion Paper on AI

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PhRMA tells FDA it strongly agrees with the potential benefits of artificial intelligence and machine learning, among three other ...

Novartis Reports Positive Data on Remibrutinib

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Novartis says top-line data from two Phase 3 studies evaluating remibrutinib 25 mg in patients with chronic spontaneous urticaria ...

Info Collection on Time and Extent Filings

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Federal Register notice: FDA seeks comments on an information collection entitled Time and Extent Applications for Nonprescription...

Guide on QTc Labeling Information

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Federal Register notice: FDA makes available a draft guidance entitled QTc Information in Human Prescription Drug and Biological P...

FDA OKs Aspen IND for Parkinsons Therapy

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Aspen says it will start a Phase 1/2a trial of its ANPD001 cell therapy to treat Parkinsons disease under an FDA-approved IND.

FDA to Review Vitaris/Mapi GA Depot NDA

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FDA accepts for review a Vitaris/Mapi ANDA for GA Depot 40 mg as a once-monthly injection to treat relapsing multiple sclerosis.

Doctors, Health Systems Should Test Generics: Article

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A Health Affairs article calls on doctors and health systems to take steps to test generic drugs to minimize risks to patients.

Law Settles Active Ingredient Debate

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A Congressional Research Service report says a 2021 law codified FDAs approach to defining a new chemical entity in regulations in...

5 Pharmas Settle Improper Reimbursement Case

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Five drug companies agree to pay $42 million to settle a Texas enforcement action involving allegedly improper reimbursements for ...