FDA Pediatric Safety Communications

… Announcement September 19, 2024 Dynacare Baby Powder FDA reports that Dynarex Corporation is recalling Dynacare … Bivona® Tracheostomy Tubes August 28, 2024 Version 2.7 of the Apple iOS t:connect Mobile App used in conjunction with … Vitamin D August 1, 2024 Geek Bar, Lost Mary, and Bang FDA warns online retailers selling unauthorized youth appealing …

Testing for Biotin Interference in In Vitro Diagnostic Devices; Guidance for Industry

… Diagnostic Devices Guidance for Industry For questions on the content of this guidance, contact Center for Biologics … (OCOD) at 240-402- 8010 or 800-835-4709, or email ocod@fda.hhs.gov. For questions about this document concerning … 2. FDA Safety Communication. The FDA Warns that Biotin May Interfere with Lab Tests. November …

2020 Annual Plain Writing Act Compliance Report

… Request for Information Background On October 13, 2010, the Plain Writing Act (Act) was signed into law. The Act … Dr. Ekaterini (Kat) Malliou at Ekaterini.Malliou@hhs.gov. [FDA] Accomplishments HHS seeks to reach all Americans with … treatments Additional Center Submissions: CBER • FDA Warns About Stem Cell Therapies: …