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Revive Rx FDA-483 Has 5 Repeat Observations

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FDA releases the form FDA-483 with five repeat observations from an inspection at Houston, TX-based Revive Rx Pharmacy.

Global Calcium FDA-483 Has 6 Observations

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FDA releases a form FDA-483 with six observations from an inspection at Indias Global Calcium active pharmaceutical ingredient man...

Ban Mercury Amalgam Fillings: Petition

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Consumers for Dental Choice and two other advocacy groups again petition FDA to ban the use of mercury amalgams in dentistry, espe...

Gene Therapy Approved for Inherited Hearing Loss

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FDA approves a Regeneron Pharmaceuticals BLA for Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherite...

FDA Not Pursuing Ban on Drug DTC Ads, Makary says

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FDA commissioner Marty Makary says the agency is not planning to eliminate direct-to-consumer pharmaceutical advertising, even as ...

2 Vet4U Inspection Observations

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FDA releases the form FDA-483 issued following an inspection at the Vet4U drug distribution facility in Clay, NY.

Redact CRLs for Unapproved Applications: Petition

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An unidentified major drug company calls on FDA to establish a process for redacting complete response letters for unapproved appl...

Senate Democrats Target Trump Drug Pricing Deals

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Senate Democrats, led by Ron Wyden (D-OR), introduce legislation aimed at forcing the Trump administration to disclose the terms o...

FDA Denies Petition to Withdraw Approval of VenaSeal

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FDA denies a citizen petition seeking to withdraw approval of Covidiens VenaSeal vein-closure system, concluding the medical devic...

FDA Expands Approval of Sanofis Tzield to Younger Children

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FDA approves an expanded indication for Sanofis Tzield (teplizumab), allowing its use in children as young as one year old to dela...