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TXT Multiple Clinical Resolution Laboratory Violations [2917 Words] [ Price : $8.95]
FDA warns Brea, CA-based Clinical Resources Laboratory about CGMP violations in its production of misbranded unapproved new drugs.
04/26/2022
 
 
TXT No Major Changes in ‘Intended Use’ Reg: Attorney [2753 Words] [ Price : $8.95]
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
 
 
TXT Repeat CGMP Violations at Vitae Enim Vitae [2921 Words] [ Price : $8.95]
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
 
 
TXT House Committee Wants Kid Covid Vaccine Briefing [2654 Words] [ Price : $8.95]
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
 
 
TXT FDA Featured in DoJ Consumer Highlights Report [2641 Words] [ Price : $8.95]
Wilson and Sontini attorneys say the Department of Justice Consumer Protection Bureau featured FDA in its “recent highlights” report.
04/26/2022
 
 
TXT FDA Withdraws 14 No-Longer-Marketed ANDAs [69 Words] [ Price : $8.95]
Federal Register notice: FDA withdraws the approval of 14 no-longer-marketed ANDAs from multiple applicants.
04/26/2022
 
 
TXT DESI Update: Anticholinergic/Antispasmodic Combo Products [130 Words] [ Price : $8.95]
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in combination with a sedative, and single-entity antispasmodic drug products, in oral dosage form, have been withdrawn.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
 
 
TXT Students Push Califf on Trial Transparency [2844 Words] [ Price : $8.95]
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
 
 
TXT Medtronic Recalls Harmony Delivery Catheter [253 Words] [ Price : $8.95]
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
 
 
TXT See if McKinsey Abused FDA Trust: Sharfstein [3214 Words] [ Price : $8.95]
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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