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3 FDA Innovative Manufacturing Action Steps

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FDA issues a strategy document on innovative manufacturing technologies with three action steps it will take.

FDA Warns 2 Chinese Labs About Data Concerns

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FDA says it sent Warning Letters to two Chinese nonclinical labs airing concerns about data integrity.

Lawsuit Against FDA Dismissed on Ripeness Grounds

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The Washington, DC District Court dismisses a Vanda Pharmaceuticals lawsuit against FDA that challenged the agencys bioequivalence...

Ocaliva Confirmatory Trial Fails: FDA

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FDA asks members of its Gastrointestinal Drugs Advisory Committee whether they believe that the benefits of using Intercepts Ocali...

GSK Nixes Herpes Simplex Virus Vaccine

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GSK decides to not advance the development of an investigational herpes simplex virus vaccine candidate based on data from a recen...

Hinge Health Wireless Pain Device Cleared

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FDA clears a Hinge Health 510(k) for its Enso 3, a wireless device for reducing musculoskeletal pain.

CDER Quantitative Medicine CoE Explained

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CDER Quantitative Medicine Center of Excellence lead Rajanikanth Madabushi explains the new units role in drug development and reg...

Follow FDA Online Misinformation Guidance: Attorneys

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Two Cooley attorneys urge companies regulated by FDA to follow the guidelines in a 7/8 draft guidance on responding to misinformat...

DeepWell Digital Software Cleared for Stress Relief

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FDA clears a DeepWell Digital Therapeutics 510(k) for its biofeedback software development kit for use in over-the-counter treatme...

Whole Exome Sequencing Devices are Class 2

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Federal Register notice: FDA classifies whole exome sequencing devices into Class 2 (special controls).