FDA Approves Drug to Reduce Risk of HIV

ASRM Bulletins July 20, 2012

Today, the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk.

FDA Warns Health Professionals to Halt Use of Other-Sonic Generic Ultrasound Transmission Gel

ASRM Bulletins April 23, 2012

An FDA press release reports, “U.S. Marshals, acting at the request of the Food and Drug Administration, have seized Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations Inc. in Newark, N.J., after an FDA analysis found that product samples contained dangerous bacteria. The agency reports that at least 16 patients from one hospital were infected with the bacteria.

FDA Issues Notice of Oral Contraceptive Recall

ASRM Bulletins March 01, 2012

The Food and Drug Administration sent the following message today to alert OB/GYNs, patients and pharmacies of  a recall of certain generic oral contraceptives.

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 This guidance finalizes the draft guidance of the same title dated January 2009.

FDA Proposes Draft Guidelines to Improve the Representation of Women in Medical Device Clinical Studies; Opportunity to Comment

ASRM Bulletins December 16, 2011

The Food and Drug Administration today issued a draft guidance document aimed to address the historic underrepresentation of women in clinical studies and is seeking comment from the public and interested parties.

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