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No Major Changes in ‘Intended Use’ Reg: Attorney
[2753 Words]
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Attorney Bryan Feldhaus says the revised FDA intended use regulation clarifies but does not change the definition of intended use and should not adversely affect off-label communications. |
04/26/2022
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Repeat CGMP Violations at Vitae Enim Vitae
[2921 Words]
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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 contract manufacturer. |
04/26/2022
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House Committee Wants Kid Covid Vaccine Briefing
[2654 Words]
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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 under age 5 and whether FDA plans to delay authorization of such vaccines until the Moderna and Pfizer emergency use authorizations can be approved at the same time. |
04/26/2022
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DESI Update: Anticholinergic/Antispasmodic Combo Products
[130 Words]
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Federal Register notice: As part of FDA’s ongoing Drug Efficacy Study Implementation, the agency announces that all outstanding hearing requests regarding drug products containing an anticholinergic or antispasmodic in combination with a sedative, and single-entity antispasmodic drug products, in oral dosage form, have been withdrawn. |
04/26/2022
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Students Push Califf on Trial Transparency
[2844 Words]
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Student advocates from Universities Allied for Essential Medicines ask to meet with FDA commissioner Robert Califf on ways to improve clinical trial results reporting. |
04/26/2022
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Medtronic Recalls Harmony Delivery Catheter
[253 Words]
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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 delivery catheter. |
04/26/2022
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See if McKinsey Abused FDA Trust: Sharfstein
[3214 Words]
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Former FDA principal deputy commissioner Joshua Sharfstein says Congress and FDA must continue to look at whether the McKinsey consulting firm abused FDA’s trust by working simultaneously for the agency and Purdue Pharma. |
04/26/2022
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