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Info Collection Extension on Formal Dispute Resolution

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Formal Dispute Resolution: Scientific and T...

FDA Confirms Pfizer 95% Covid Vaccine Efficacy

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FDA advisory committee briefing information confirms 95% efficacy with Pfizer-BioNTechs Covid-19 vaccine.

Zebra Medical Orthopedic Surgical Planner Cleared

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FDA clears a Zebra Medical Vision 510(k) for its artificial intelligence analytics that extract bone measurements from X-ray scans...

Juno Therapeutics FDA-483

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FDA publishes the FDA-483 with six inspection observations issued to Juno Therapeutics.

Proprietary Name Guidances

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FDA issues guidances with recommended best practices to use in developing proprietary names for human prescription and non-prescri...

Administration Argues Covid Not Risky for Abortion Pill Patients: ACLU

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The ACLU says federal courts should continue to block an FDA policy requiring patients seeking mifepristone to appear in person at...

38 Project Orbis Approvals in First Full Year

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FDA says the Oncology Center of Excellences Project Orbis received 60 applications in its first full year of existence and approve...

Turning Point Breakthrough Status for Lung Cancer Drug

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FDA grants Turning Point Therapeutics a breakthrough therapy designation for repotrectinib and its use in treating certain patient...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Natures Boost and Valentus.

Biden Taps CA Attorney General as HHS Secretary

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President-elect Joe Biden names California attorney general Xavier Becerra as his nominee for HHS secretary, a sign that an FDA co...