News & Publications

FDA Announcements

This Web page contains links to miscellaneous U.S. Food and Drug Administration (FDA) announcements that ASRM felt were relevant enough to archive on the ASRM Web Site. You can visit the FDA's web site at http://www.fda.gov/ 

FDA to Host Scientific Workshop on Labeling of Lower-Dose Estrogen Products Used to Treat Symptoms of Menopause

ASRM Bulletins October 08, 2015

The U.S. Food and Drug Administration (FDA) has announced it is seeking public comment on the labeling for lower-dose estrogen products delivered vaginally and intended to treat symptoms of vulvar and vaginal atrophy due to menopause.  It will hold a scientific workshop to seek expert opinions on whether the current “Boxed Warnings” section in the labeling is applicable in whole or in part to these lower-dose estrogen products.

ASRM and SMRU Respond to FDA on Drug Development

ASRM Bulletins October 01, 2015

ASRM and its affiliated society the Society for Male Reproduction and Urology (SMRU) jointly submitted a comment letter regarding draft guidelines the Food and Drug Administration (FDA) has issued entitled, “Testicular Toxicity: Evaluation During Drug Development.”

FDA’s Obstetrics and Gynecology Devices Panel Will Meet on September 24, 2015 to Discuss the Essure System

ASRM Bulletins July 29, 2015

The OB/Gyn Devices Panel of FDA’s Medical Devices Advisory Committee is convening to seek expert scientific and clinical input on the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization.

FDA Issues Final Guidance on Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells

ASRM Bulletins January 11, 2012

The U.S. Food and Drug Administration has issued final guidance and has announced the availability of a document entitled ‘‘Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).’’ This guidance finalizes the draft guidance of the same title dated January 2009.

Medical Product Safety Network (MedSun)

FDA Announcements May 14, 2010

The program called MedSun (Medical Product Safety Network), is designed to improve the understanding of medical device use so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns.

FDA Jurisdiction over clinical research using cloning technology to clone a human being

FDA Announcements May 05, 2008

To all ASRM Members: The purpose of this notice is to remind the ASRM and its members that the Food and Drug Administration (FDA) has jurisdiction over clinical research using cloning technology to clone a human being, and to inform you of the FDA regulatory process that is required.

FDA Issues Regulations on Human Cells, Tissues, and Cellular and Tissue-Based Products

FDA Announcements September 22, 2006

The FDA has issued regulations modifying the donor eligibility final rule and the current good tissue practices final rule. All of these rules will take effect May 25, 2005. 

Summary Of “Eligibility Determination For Donors Of Human Cells, Tissues, And Cellular And Tissue-Based Products”

FDA Announcements September 22, 2006

On May 25, 2005, FDA’s final rule, “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products,” became effective, modified by an interim final rule published and made effective on the same day.

FDA Menopause & Hormones Fact Sheet (PDF)

FDA Announcements December 29, 2005

 View the Menopause & Hormones Fact Sheet (PDF) created by the FDA

FDA MedWatch - Paxil/Paxil CR (paroxetine HCl) Public Health Advisory

FDA Announcements December 15, 2005

Exposure in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations

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