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TXT Howard Head Debarred for 5 Years [70 Words] [ Price : $8.95]
Federal Register notice: FDA debars for five years Howard Stanley Head from importing or offering for import any drug into the U.S.
05/16/2022
 
 
TXT Final Guide on Investigating Out-of-spec Results [463 Words] [ Price : $8.95]
FDA posts a final guidance entitled “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.”
05/16/2022
 
 
TXT Avanos Recalls Cortrak 2 Enteral Access Device [146 Words] [ Price : $8.95]
Avanos Medical recalls (Class 1) its Cortrak 2 Enteral Access System due to reports of injuries and patient deaths after nasoenteric or nasogastric tubes have been misplaced in patients.
05/16/2022
 
 
TXT New Home Covid Test Gives Results for Flu, RSV too [118 Words] [ Price : $8.95]
FDA issues an Emergency Use Authorization (EUA) for the Labcorp’s Covid-19+Flu+RSV Test Home Collection Kit for use with the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test.
05/16/2022
 
 
TXT Nature Examines Potential Accelerated Approval Reforms [486 Words] [ Price : $8.95]
The journal Nature examines the problems with FDA’s accelerated approval program and potential reforms to reduce any gaming by the pharmaceutical industry.
05/13/2022
 
 
TXT HIV Tests Down Classified to 510(k) [116 Words] [ Price : $8.95]
Federal Register notice: FDA issues a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid diagnostic and supplemental tests from postamendments Class 3 devices into Class 2 (510(k)).
05/13/2022
 
 
TXT BridgeBio Pharma Sells Review Voucher for $110 Million [82 Words] [ Price : $8.95]
BridgeBio Pharma sells for $110 million its priority review voucher that was awarded last year when FDA approved Nulibry (fosdenopterin) for an ultra-rare disease.
05/13/2022
 
 
TXT Inspection Findings Sideline UCB Psoriasis Drug [129 Words] [ Price : $8.95]
FDA sends UCB a complete response letter on its BLA for psoriasis-treating bimekizumab, citing deficiencies from a recent preapproval inspection as the reason.
05/13/2022
 
 
TXT Scathing FDA-483 Hits Sun Pharma Over GMPs [208 Words] [ Price : $8.95]
A just-released, scathing (XXX INSERT XXX)23-page Form FDA-483 cites 10 GMP deficiencies at Sun Pharmaceutical Industries’ Halol manufacturing facility (Gujarat, India).
05/13/2022
 
 
TXT Lilly Once-weekly Diabetes Injection Approved [262 Words] [ Price : $8.95]
FDA approves an Eli Lilly NDA for Mounjaro (tirzepatide), a once-weekly injection to improve blood sugar control in adults with Type 2 diabetes, as an addition to diet and exercise.
05/13/2022
 
 
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