Categories
rss rss-es rss-pt

FDA Recommends Transition from Use of Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities

Murilo Freitas - 04:00, 26 de mayo de 2021407
Read more on the domestic supply of new respirators, including N95s and other FFRs, elastomeric respirators, powered air-purifying respirators (PAPRs)

http://www.fda.gov/medical-devices/letters-health-care-providers/fda-recommends-transition-use-decontaminated-disposable-respirators-letter-health-care-personnel-and

 
Categories
rss rss-es rss-pt

Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication – Due to Risk of Serious Liver Injury, FDA Restricts Use of Ocaliva in Primary Biliary Cholangitis Patients with Advanced Cirrhosis

Murilo Freitas - 16:00, 25 de mayo de 2021469
FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis with advanced cirrhosis of the liver because some patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed liver failure

http://www.fda.gov/safety/medical-product-safety-information/ocaliva-obeticholic-acid-intercept-pharmaceuticals-drug-safety-communication-due-risk-serious-liver

 
Categories
rss rss-es rss-pt

FDA In Brief: FDA Announces Draft Guidances to Help Increase Transparency, Assist Reporting and Timely Completion for Certain Medical Device Studies after FDA Approval or Clearance

Murilo Freitas - 13:41, 25 de mayo de 2021394

FDA In Brief: FDA Announces Draft Guidances to Help Increase Transparency, Assist Reporting and Timely Completion for Certain Medical Device Studies after FDA Approval or Clearance
http://www.fda.gov/news-events/press-announcements/fda-brief-fda-announces-draft-guidances-help-increase-transparency-assist-reporting-and-timely

 
PRAIS 2.0