Message from the Director
In March, we take time to celebrate and applaud the efforts of women who worked to make America a safer place in areas of medical devices and drug development. This month, celebrate Women’s History Month by reading how women have made historic contributions to health and science at FDA. I also encourage you to learn how FDA has impacted women’s health over the years.
Marsha Henderson, Assistant Commissioner for Women’s Health
WOMEN'S HEALTH HIGHLIGHTS
2016 OWH Research Grants
OWH has selected 15 research projects for FY 2016 funding. Projects were selected based on the Research Roadmap 7 priority areas.
The outcomes of the research will help FDA develop innovative approaches to identify and evaluate sex differences and assess the safety and efficacy of medical products used by women.
New Article on Impact of OWH Research on Regulatory Policy
OWH funds research to help FDA evaluate sex differences in product safety and efficacy and to advance the science of women’s health. A new article in the Journal of Women’s Health highlights the impact of OWH-funded research on FDA guidance to industry, product labeling, safety notices, and clinical practice.
Read the Article: The Food and Drug Administration Office of Women’s Health: Impact of Science on Regulatory Policy: An Update
Visit the Women’s Health Research page
Update on FDA’s Evaluation of Essure
The FDA announced actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. FDA issued a new, mandatory clinical study for Essure to determine heightened risks for particular women.
The FDA also intends to require changes to product labeling, including a boxed warning and a Patient Decision Checklist to help to ensure women receive and understand information regarding the benefits and risks of this type of device.The FDA has issued a draft guidance to provide the public an opportunity to comment on the proposed language to be included in these warnings.
Women and Girls HIV/AIDS Awareness Day
On March 10th, use FDA resources to help amplify your voice about HIV/AIDS awareness and encourage women living with HIV to participate in clinical trials. Use these resources in your outreach to teach women about HIV testing, prevention and treatment.
Use the HIV – Medicines to Help You guide to teach women with HIV about the questions to ask about their medicines.
Learn more about FDA’s HIV and AIDS activities
Get involved by using HIV/AIDS resources from HHS Office on Women’s Health
FDA Welcomes Dr. Califf as the New FDA Commissioner
Robert M. Califf, M.D., was confirmed by the Senate on Wednesday, Feb. 24, 2015, as the Agency’s 22nd Commissioner of Food and Drugs. He is a respected cardiologist and internationally known expert in cardiovascular medicine, health outcomes research, and clinical research.
Safe Spring Break Resources
Are you or someone you know excited about Spring Break? Prepare for a fun time with health and safety tips from FDA. Share these digital tools with your networks to help keep students safe.
Read the 5 Tips for a Safer Spring Break
Link to the College Women’s Health page
Follow @FDAWomen on Twitter for Spring Break tips
New Health Fraud video from FDA Office of Minority Health
In observance of the National Consumer Protection Week, from March 6-12, the FDA is launching a new multimedia and multilingual initiative in English, Spanish, Simplified Chinese, Korean, Vietnamese, and Tagalog to alert consumers of the dangers of imported tainted products falsely marketed as dietary supplements.
Download the consumer article: “Not All Imported Products Sold as “Supplements” Are Safe”
Download the supplement safety educational videos
Visit the FDA Health Fraud page for more resources
Visit FDA’s Flicker albums for photos of tainted products
FDA MEETINGS AND WEBINARS
March 10, 2016, 2:00 pm to 3:00 pm, Webinar
March 17, 2016, 10:00 am to 4:00 pm, FDA White Oak Campus
FDA/University of Maryland’s Center of Excellence in Regulatory Science and Innovation (CERSI) Public Workshop on Medical Devices
March 24, 2016, 8:30am to 4:30pm, UMD Baltimore
Submit Comments on FDA Regulatory Activities
Food and Drug Administration Safety and Innovation Act 907 Public Meeting: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data
This docket is open until April 29, 2016.