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Multiple Clinical Resolution Laboratory Violations

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FDA warns Brea, CA-based Clinical Resources Laboratory about CGMP violations in its production of misbranded unapproved new drugs.

No Major Changes in Intended Use Reg: Attorney

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Attorney Bryan Feldhaus says the revised FDA intended use regulation clarifies but does not change the definition of intended use ...

Repeat CGMP Violations at Vitae Enim Vitae

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FDA warns San Diego, CA-based Vitae Enim Vitae Scientific about repeat CGMP violations in its work producing finished drugs as a c...

House Committee Wants Kid Covid Vaccine Briefing

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The House Select Subcommittee on the Coronavirus Crisis is asking for an FDA briefing on the status of vaccination for children un...

FDA Featured in DoJ Consumer Highlights Report

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Wilson and Sontini attorneys say the Department of Justice Consumer Protection Bureau featured FDA in its recent highlights report...

FDA Withdraws 14 No-Longer-Marketed ANDAs

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Federal Register notice: FDA withdraws the approval of 14 no-longer-marketed ANDAs from multiple applicants.

DESI Update: Anticholinergic/Antispasmodic Combo Products

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Federal Register notice: As part of FDAs ongoing Drug Efficacy Study Implementation, the agency announces that all outstanding hea...

Students Push Califf on Trial Transparency

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Student advocates from Universities Allied for Essential Medicines ask to meet with FDA commissioner Robert Califf on ways to impr...

Medtronic Recalls Harmony Delivery Catheter

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Medtronic recalls its Harmony Delivery Catheter due to the potential for a break in the bond holding the capsule at the end of the...

See if McKinsey Abused FDA Trust: Sharfstein

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Former FDA principal deputy commissioner Joshua Sharfstein says Congress and FDA must continue to look at whether the McKinsey con...