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TXT FDA Updates Philips Respironics Recall Info [2664 Words] [ Price : $8.95]
FDA updates its communications about Philips Respironics recalls of ventilators and BiPAP and CPAP machines.
05/19/2022
 
 
TXT ISPE Wants Longer Device Quality System Implementation [2756 Words] [ Price : $8.95]
Three medical device stakeholders express support for a proposed FDA change to the quality system regulation to incorporate an international standard for quality management.
05/19/2022
 
 
TXT Medical Journals Need Better Conflict Disclosures: Article [344 Words] [ Price : $8.95]
Public Citizen’s Sidney Wolfe and Weill Cornell Medical College professor Martin F. Shapiro urge medical journals to step up their transparency efforts regarding disclosures about the “relationships of authors to companies with financial interests related to topics they write about.”
05/19/2022
 
 
TXT Woodcock Assisting 7 Offices/Centers; Not Drugs/Biologics [787 Words] [ Price : $8.95]
FDA commissioner Robert Califf taps FDA principal deputy commissioner Janet Woodcock to counsel and support seven offices and Centers, but drugs and biologics — the two areas that her previous experience has covered — are noticeably not among them, leading to speculation about her future.
05/19/2022
 
 
TXT Science Board to Discuss Cannabinoids, Animal Studies [106 Words] [ Price : $8.95]
FDA schedules its Science Board to the Food and Drug Administration Advisory Committee to consider challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, utilizing cannabinoids as a case study, and it will discuss enhanced efforts to spur the adoption of new alternative methods for regulatory use that can replace animal testing.
05/18/2022
 
 
TXT DoJ Sues Prometheus Over Device Use [2729 Words] [ Price : $8.95]
The Justice Department sues The Prometheus Group and its owner for allegedly recommending that single-use medical devices be used on multiple patients.
05/18/2022
 
 
TXT Patel Joins Google Health [2698 Words] [ Price : $8.95]
Former FDA Digital Health Center of Excellence director Bakul Patel joins Google and Alphabet as a senior director for global health strategy and regulatory.
05/18/2022
 
 
TXT Woodside Acquisitions Covid Test Recall is Class 1 [2664 Words] [ Price : $8.95]
FDA says a Woodside Acquisitions recall of some 51,000 unapproved Covid-19 antigen tests is Class 1.
05/18/2022
 
 
TXT FDA Clears CTL Amedica Pedicle Screw Navigator [92 Words] [ Price : $8.95]
FDA clears a CTL Amedica 510(k) to market the CTL Amedica Navigation Instrument System for use in pedicle screw preparation and placement.
05/18/2022
 
 
TXT FDA Denies Part of Contraceptive Study Group Petition [2718 Words] [ Price : $8.95]
FDA denies a portion of a 2019 petition asking for a Boxed Warning on breast cancer risk for combined hormonal contraceptives.
05/18/2022
 
 
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