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Technical Amendment on Animal Drug Regs

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Federal Register notice: FDA posts a technical amendment to its animal drug regulations for labeling new animal drugs included on ...

FDA OKs Roche HPV Self-Collection Solution

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FDA approves the Roche HPV self-collection solution that the company says can expand access and screening options to help eliminat...

CGMP Violations in Health Specialty Inspection

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FDA warns Omaha, NE-based Cohere Beauty about CGMP violations in its Health Specialty drug manufacturing facility in Santa Fe Spri...

55 Novel Drugs Approved in 2023: Report

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The CDER Drug Trials Snapshop Summary Report 2023 provides statistics on the 55 novel drugs the Center approved in 2023.

Juno Therapeutics Breyanzi Approved for Lymphoma

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FDA grants Juno Therapeutics accelerated approval for its BLA for Breyanzi (lisocabtagene maraleucel), a CAR T cell therapy for ad...

Rep Green Bill on Vaccine Data Transparency

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Rep. Mark Green (R-TN) introduces the Vaccines in Trial and Liability Act of 2024 that would ensure Americans are protected from f...

CGMP Violations in Grupo Contract Test Lab

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FDA warns Uruguays Grupo Quimico SRL about CGMP violations in its work as a contract testing laboratory for drug companies.

Day One Bio Granted Pediatric Voucher

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Federal Register notice: FDA announces that it issued Day One Biopharmaceuticals a priority review voucher for its recently approv...

FDA Clears Qiagens Respiratory Panel Plus

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FDA clears a Qiagen 510(k) for the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use in diagnosing upper respirato...

FDA Warns Westwood Labs on CGMP Violations

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FDA warns Azusa, CA-based Woodward Laboratories about CGMP violations in its production of finished drugs.