FDA Drug Safety Communication: FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products

Safety Announcement [6-25-2014] The U.S. Food and Drug Administration (FDA) is warning that certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation.  Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness;…

FDA Drug Safety Communication: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required

Data Summary  FDA has completed a safety review of olmesartan and cardiovascular risk that was prompted by results of the ROADMAP (Randomized OlmesArtan and Diabetes MicroAlbuminuria Prevention) trial and ORIENT (Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial).  These studies suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic…

Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products

PDF Version (PDF – 156KB) This guidance document is for comment purposes only. Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance.  Submit electronic comments to http://www.regulations.gov.  Submit written comments to the Division of Dockets…

Draft Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis)

  I. Introduction II. Background III. Recommendations IV. References Reference Information: About this guidance document To obtain copies of this document For questions regarding this document FDA office that authored this guidance October 2013 Return to Table of Contents Return to Table of Contents http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm095440.htm. Return to Table of Contents FDA Guidance for Industry: Eligibility Determination for…

Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

I. Introduction II. Background III. Recommendations for Testing Donors of HCT/Ps IV. Implementation V. References Footnotes Reference Information: About this guidance document How to comment on this document To obtain copies of this document For questions regarding this document FDA office that authored this guidance October 2013 Return to Table of Contents II. BACKGROUND A. Regulatory Background…

Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events

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