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TXT Increase FDA Oversight of Lab-developed Tests: Pew [287 Words] [ Price : $8.95]
A new Pew Charitable Trusts survey on lab-developed tests finds that most participants would favor increased FDA oversight in this space.
05/06/2022
 
 
TXT Califf Returned to FDA for ‘Unfinished Business’ [872 Words] [ Price : $8.95]
FDA commissioner Robert Califf admits that his return to the FDA top post gives him an opportunity to address “unfinished business from the first time around.”
05/06/2022
 
 
TXT Lasik Injury Advocate Steps Up Pressure on ‘Illegal Ads’ [253 Words] [ Price : $8.95]
Lasik injury advocate and Vision Advocacy president Paula Cofer steps up pressure to get FDA commissioner Robert Califf’s attention to address “illegal” advertising by refractive eye surgeons.
05/06/2022
 
 
TXT Toxic Risk with Fresenius Hemodialysis Machines: FDA [306 Words] [ Price : $8.95]
FDA warns about the potential risk of exposure to toxic non-dioxin-like polychlorinated biphenyl acids and polychlorinated biphenyls with certain Fresenius Medical Care hemodialysis machines.
05/06/2022
 
 
TXT FDA Orders Partial Clinical Hold on BioCryst Therapy [203 Words] [ Price : $8.95]
FDA issues a partial clinical hold on BioCryst clinical trial of its oral Factor D inhibitor, BCX9930 due to observed elevations in serum creatinine seen in some patients.
05/05/2022
 
 
TXT Info Collection on Antimicrobial Animal Drug Reporting [122 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled “Antimicrobial Animal Drug Distribution Reports and Recordkeeping — 21 CFR 514.87.
05/05/2022
 
 
TXT Psychiatrist Blasts Clozapine REMS [2887 Words] [ Price : $8.95]
Psychiatrist Brian Barnett says FDA should remove itself from neutrophil monitoring requirements for patients on clozapine and leave the issue to prescribers.
05/05/2022
 
 
TXT Glycemic Control Device Guidance [2637 Words] [ Price : $8.95]
FDA publishes a guidance with recommendations for feasibility and early feasibility studies in medical devices intended to improve glycemic control in patients with Type 2 diabetes.
05/05/2022
 
 
TXT User Fee Bill Aims to Correct Court Decisions [536 Words] [ Price : $8.95]
A House Energy and Commerce Committee legislative package to reauthorize FDA user fee agreements aims to address agency predicaments caused by recent court decisions affecting orphan drug exclusivity and the regulation of contrast agents.
05/05/2022
 
 
TXT Guide on Radiolabeled Mass Balance Studies [72 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies.”
05/05/2022
 
 
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