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TXT FDA Drug ‘Recall-Ready’ Tips [2698 Words] [ Price : $8.95]
A CDER podcast gives drug companies steps to follow to be better able to handle recalls quickly and efficiently.
04/20/2022
 
 
TXT 2019 NARMS Integrated Summary Out [2694 Words] [ Price : $8.95]
FDA releases the 2019 National Antimicrobial Resistance Monitoring System Integrated Summary showing that salmonella resistance in humans remained steady.
04/20/2022
 
 
TXT American Regent Production Supervisor Sentenced [2662 Words] [ Price : $8.95]
The Justice Department says an American Regent drug production supervisor has been sentenced to jail time and payment of restitution for stealing thousands of bottles of an equine drug.
04/20/2022
 
 
TXT Study on Physician Use of Off-label ‘Unsupportive Data’ [428 Words] [ Price : $8.95]
A new study about the influence of data disclosures on physician decisions about off-label uses suggests that there is limited awareness of, and exposure to, unsupportive data about off-label uses among physicians.
04/20/2022
 
 
TXT FDA Needs Procedures for Reporting Political Interference: GAO [678 Words] [ Price : $8.95]
A new Government Accountability Office report recommends that FDA and other HHS agencies develop procedures for reporting and addressing allegations of political interference.
04/20/2022
 
 
TXT FDA Rejects Teva/MedinCell Risperidone NDA [182 Words] [ Price : $8.95]
FDA issues Teva Pharmaceuticals and MedinCell a complete response letter on their NDA for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for treating schizophrenia.
04/20/2022
 
 
TXT NCTR Science Advisory Board Panel Meeting [89 Words] [ Price : $8.95]
Federal Register notice: FDA announces a 5/18-19 meeting of the Science Advisory Board to the National Center for Toxicological Research (NCTR) Advisory Committee to provide updates on scientific initiatives.
04/20/2022
 
 
TXT 12 Warning Letters Sent to Skin Bleaching Marketers [165 Words] [ Price : $8.95]
Based on adverse events received, FDA sends Warning Letters to 12 companies for selling unapproved over-the-counter products intended to bleach or lighten the skin.
04/19/2022
 
 
TXT Drug Companies Must Assume Messaging Risks: Attorneys [2713 Words] [ Price : $8.95]
Two Arnall Golden Gregory attorneys recommend that drug companies keep all FDA promotion regulations in mind when they craft consumer and professional communications.
04/19/2022
 
 
TXT Regenerative Stem Cell Institute Unapproved Cell Products [2739 Words] [ Price : $8.95]
FDA says the Elgin-IL-based Regenerative Stem Cell Institute is marketing cellular products without an approved BLA or IND.
04/19/2022
 
 
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