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TXT Info Collection: Antimicrobial Distribution Reporting [123 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled “Antimicrobial Animal Drug Distribution Reports and Recordkeeping — 21 CFR 514.87.”
11/09/2021
 
 
TXT Biogen Probes Fatal Case of Aduhelm Patient [390 Words] [ Price : $8.95]
Biogen says it is investigating the death of a 75-year-old patient who had taken the company’s controversial Alzheimer’s drug Aduhelm (aducanumab).
11/09/2021
 
 
TXT Shorter Antibiotic Use Effective in 2 Uses: Studies [2779 Words] [ Price : $8.95]
FDA says research it funded demonstrated that in two contexts shorter courses of antibiotic treatment were as effective as longer courses, reducing the chance for antibiotic resistance.
11/09/2021
 
 
TXT CHPA Recommendations for Implementation of Genus Decision [2756 Words] [ Price : $8.95]
The Consumer Healthcare Product Association recommends four steps FDA should take in implementing an appeals court decision on regulating drug/device combination products.
11/09/2021
 
 
TXT CGMP Violations at Adamson Analytical Labs [2822 Words] [ Price : $8.95]
FDA warns Adamson Analytical Laboratories about repeat CGMP violations in its work as a contract testing laboratory.
11/09/2021
 
 
TXT ORA Embraces Remote Evaluations in Post Pandemic Arena [585 Words] [ Price : $8.95]
FDA Office of Regulatory Affairs assistant commissioner Elizabeth Miller tells an industry conference that her office has embraced the flexibility and information-enhancing abilities that alternative inspection tools, such as remote interactive evaluations, have provided agency during the pandemic, and they will continue to be available long after Covid-19 ends.
11/09/2021
 
 
TXT Study Questions Some Accelerated Approval Uses [2735 Words] [ Price : $8.95]
Yale University researchers say giving sponsors extended periods to complete post-accelerated approval studies may not be justified.
11/09/2021
 
 
TXT Research Uncovers Cyber Security Flaws in Device Software [121 Words] [ Price : $8.95]
New research uncovers numerous software vulnerabilities in medical devices.
11/09/2021
 
 
TXT Electronic Submission of eSTAR 510(k)s Needed: Consultant [2708 Words] [ Price : $8.95]
Medical device regulatory consultant Adrienne Lenz says FDA needs to develop a way for medical device manufacturers to transmit electronic 510(k) submissions to the agency electronically.
11/09/2021
 
 
TXT Arthrex Paying $16 Million to Resolve Kickback Case [2688 Words] [ Price : $8.95]
The Justice Department says Arthrex is paying $16 million to resolve a whistleblower’s allegations of kickbacks leading to False Claims Act payments.
11/09/2021
 
 
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