1. Home
  2. Science & Research
  3. About Science & Research at FDA
  4. FDA Grand Rounds
  5. FDA Grand Rounds presented by the Office of Women’s Health: FDA Menopausal Hormone Therapy (MHT) Labeling: Historical Context and Recent Changes - 04/23/2026
  1. FDA Grand Rounds

Webcast | Virtual

Event Title
FDA Grand Rounds presented by the Office of Women’s Health: FDA Menopausal Hormone Therapy (MHT) Labeling: Historical Context and Recent Changes
April 23, 2026

Date:
April 23, 2026
Time:
12:00 p.m. - 1:00 p.m. ET

To Attend

For technical assistance please contact: Rakesh.Raghuwanshi@fda.hhs.gov

Speakers
 

Nicholas Hazen, M.D.

Nicholas Hazen, M.D.
Medical Officer

Aisha Johnson, M.D., MPH, MBA

Aisha Johnson, M.D., MPH, MBA
Deputy Director for Safety
Associate Director for Labeling

Division of Urology, Obstetrics, and Gynecology
Office of New Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

About the Speakers

Dr. Nicholas Hazen is an OBGYN physician, gynecologic surgeon, and medical officer in the FDA's Office of New Drugs’ Division of Urology, Obstetrics, and Gynecology. He received his undergraduate degree in computer science from New York University and worked in the telecommunications industry for nearly a decade before earning his M.D. from George Washington University. He completed his medical residency in OBGYN and a fellowship in Minimally Invasive Gynecologic Surgery (MIGS) at Medstar Georgetown University/Washington Hospital Center before becoming an assistant professor at Georgetown, where he served in multiple leadership roles, many involving MIGS. In 2024, Dr. Hazen left full-time clinical practice to join the FDA. He still maintains a small gynecology practice at Georgetown and continues to serve as a surgical mentor and direct the residency's simulation program. Dr. Hazen has received multiple awards and recognitions including Association of Professors of Gynecology and Obstetrics Excellence in teaching award, and Washingtonian Magazine’s Top Doctor. He has authored many peer-reviewed articles covering a wide range of subjects in both obstetrics and gynecology.

Dr. Aisha Johnson is a family and preventive medicine physician currently serving as the Deputy Director for Safety and Associate Director for Labeling in the Division of Urology, Obstetrics, and Gynecology in the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. Prior to this role, Aisha was a medical officer in the Office of Compliance, Good Clinical Practice Assessment Branch where she was involved in activities related to clinical site inspections. She joined the FDA in 2007, starting in the Division of Gastroenterology and Inborn Errors Products as a medical officer. Dr. Johnson earned a Bachelor of Science in chemistry in 1997 from Howard University and her Medical Degree from the University of Maryland in 2001. She completed a family medicine residency at Florida Hospital Orlando and subsequently completed a preventive medicine residency at Johns Hopkins. She also obtained Master of Business Administration and Master of Public Health degrees from Johns Hopkins. Currently, Dr. Johnson holds an active license to practice medicine in Maryland and board certifications in family medicine from the American Board of Family Medicine and preventive medicine from the American Board of Preventive Medicine.

About the Presentation

This lecture will provide the historical and regulatory context of menopausal hormone therapy (MHT) which led to the creation of the Women's Health Initiative studies, as well as the results of those studies and the subsequent impact. The lecture will also describe the rationale for the FDA’s requests to update the MHT labeling and describe the labeling changes in each of the four MHT product categories.

Learning Objectives

  1. Describe the relevant history of MHT products prior to the WHI (Women’s Health Initiative)
  2. Describe the regulatory history of MHT use prior to the WHI
  3. Describe the study data that lead to creation of the WHI  
  4. Describe the MHI results and reasons for stopping
  5. Describe the rationale for FDA’s requests to update MHT labeling
  6. Describe the labeling changes in each of the four MHT product categories

Continuing Medical Education (CME) Credit

As CME credit is being offered through the Johns Hopkins University School of Medicine, those wishing to obtain CME credit must create a user profile on the Hopkins Cloud CME platform. If you have never had a CME certificate/credits awarded and need a user profile created, please log onto https://hopkinscme.cloud-cme.com and click the “Sign Up Now” button. DO NOT create a new account if you have already received credit for Johns Hopkins CME activities at any time. Click on Forgot Password if you already have an email on file with the JHU OCME office. Instructions on how to claim the CME credit will be provided during the Grand Rounds presentation, but participants must already have a Hopkins Cloud CME user profile before the presentation.

Accreditation Statement

The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation Statement

The Johns Hopkins University School of Medicine designates this live activity for a maximum of 1 AMA PRA Category 1 Credit. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This regularly scheduled series has been approved for a 52-week cycle beginning October 23, 2025.

Other Credits

Reciprocity exists with the following boards that accept AMA PRA Category 1 Credits™ from organizations accredited by the ACCME:

  • American Nurses Credentialing Center
  • American Academy of Nurse Practitioners National Certification Program
  • National Commission on Certification of Physicians Assistants
  • Psychologists: JHUSOM is authorized by the Maryland State Board of Examiners of Psychologists as a provider of continuing education. The JHUSOM maintains responsibility for this program.
  • Social Workers: The Maryland Board of Social Work Examiners certifies that this program meets the criteria for 1 credit hour of Category 1 of continuing education for social workers licensed in Maryland. The JHUSOM is an approved sponsor of the Maryland Board of Social Work Examiners for continuing education credits for licensed social workers in Maryland.

These professionals should submit their transcript to their respective boards to convert their credits to CEUs.

Policy on Presenter and Provider Disclosure

It is the policy of the Johns Hopkins University School of Medicine that the presenter globally disclose conflicts of interest and any discussion of unlabeled/unapproved uses of drugs or devices during their presentation(s). The Johns Hopkins University School of Medicine OCME has established policies in place to identify and mitigate relevant conflicts of interest prior to this educational activity. Detailed disclosure will be made prior to presentation of the education.

Back to Top