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FDA to Warn About Severe Reactions with Covid Vaccine: Marks

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CBER director Peter Marks says FDA plans to warn patients whove had previous severe reactions after being vaccinated about such ri...

Natures Boost Selling Unapproved New Drugs: FDA

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FDA warns Natures Boost that it is marketing misbranded unapproved new drugs.

FDA Says Valentus Marketing Several Unapproved New Drugs

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FDA warns Valentus, Inc., that it is taking orders for misbranded unapproved new drugs.

Guide on Combo Product Feedback Meetings

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FDA posts a final guidance on Requesting FDA Feedback on Combination Products.

Info Collection Extension on Formal Dispute Resolution

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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...