February 23, 2024

Dear Colleague,

While the FDA continues to focus on protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products, we also recognize the work of our public health partners. As public health advocates, we know that your work to better our country is invaluable. Your partnership, knowledge and engagement in the public health space are appreciated.

Updates

• February 20, 2024 - FDA Roundup
• February 20, 2024 – The Vital Importance of Working in Partnership with Other Regulators – An Interview with MHRA’s CEO Dr. June Raine
• February 16, 2024 - FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma
• February 16, 2024 - FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure
• February 16, 2024 - FDA Roundup
• February 14, 2024 - Education Efforts to Help Increase Biosimilar Understanding and Acceptance

Spotlight!

Consumer Updates

Always Tired? You May Have Sleep Apnea

Do you feel tired or have a headache when you wake up in the morning? Something might be going wrong while you sleep that you don’t know about: obstructive sleep apnea (pronounced app-nee-uh).

Keeping Your Milk Safe From the Grass to the Glass

Milk is one of the safest foods we can consume in the U.S. today. That wasn’t always the case. If you look back 100 years, milk was second only to water as a vehicle for transmitting disease, as noted in a 1924 U.S. Public Health Service article.

FDA Voices

FDA Science, Research, and Collaboration Advance Generic Medicines

By: Iilun Murphy, M.D., Director, Office of Generic Drugs, Center for Drug Evaluation and Research

Guidance Documents

Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

The FDA is issuing this guidance to provide sponsors and investigators with considerations for approaches on how common COVID-19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adult and adolescent subjects.

Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance

The FDA has developed this draft guidance to propose select updates to the FDA guidance document Medical Device User Fee Small Business Qualification and Certification. This guidance provides additional information for the granting of the small business registration fee waiver. The existing guidance on small business user fees remains in effect, in its current form, until this draft guidance is finalized.

View all Official FDA Guidance Documents and other Regulatory Guidance
You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

Webinars and Virtual Workshops

FDA/CDER and American Association of Pharmaceutical Scientists (AAPS) Hybrid Public Workshop

February 26, 2024; 9 a.m. - 4:30 p.m. ET

This workshop will explore the current state of the science in the field of therapeutic drug monitoring (TDM) for biologic products and current clinical practice in the United States and Europe. The potential benefits, limitations, and future considerations for TDM of large molecule therapeutics will be discussed.

HHS Black Health Forum

Wednesday, February 28, 2024; 9 - 11:30 a.m. ET

At this Forum, senior HHS, Biden-Harris Administration, and Black health leaders will highlight their work to improve equity and access to health care in the Black community. The Forum topics will focus on health care access, mental health, maternal mortality, and much more.

Product Quality Research Institute (PQRI) Workshop: MIDD Approaches in Pediatric Formulation Development

February 28 - 29, 2024

Day1: Wed, Feb 28; 8:30 a.m. - 2:30 p.m. ET

Day2: Thu, Feb 29; 8:30 a.m. - 2:30 p.m. ET

The objective of this workshop is to bring together industry, regulators, and academia to develop strategies to overcome current challenges with pediatric formulation development.

Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes

March 7, 2024; 1 - 2:30 p.m. ET

This webinar will discuss how and when to work with FDA to improve your integrated safety analyses and obtain answers to questions you may have about your application. In addition, common mistakes seen in integrated analyses will be discussed to help you avoid making the same mistakes.

View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

About Us

The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. For more information, please contact us at: FDAStakeholderEngagement@fda.hhs.gov.