March 9, 2026

Dear Colleague,

The FDA works to safeguard the public against potential health risks, ensures the safety and efficacy of medical products, and the safety of our nation’s food supply and cosmetics.  Your partnership, knowledge and engagement in the public health space are appreciated.

Sincerely,

The Public Engagement Staff

Public Engagement Staff | FDA

Updates

• March 9, 2026 - FDA Takes Further Steps to Streamline Biosimilar Development and Make Medicines More Affordable
• March 9, 2026 - FDA Approves First Generic Robenacoxib Injectable for Postoperative Pain and Inflammation in Dogs and Cats
• March 6, 2026 - FDA Announces Newly Indexed Drug to Treat Parasites in Ornamental Finfish
• March 6, 2026 - FDA Holds Meeting with States on Importation of Lower Cost Drugs
• March 5, 2026 - FDA Grants Third Approval Under the National Priority Voucher Program
• March 5, 2026 - FDA and Partners in the Central Coast Agricultural Region of California Share Findings from Multi-year Environmental Study
• March 5, 2026 - FDA to Address Unused Opioids in American Homes
• March 4, 2026 - National Drug Code Format
• March 4, 2026 - Investigations of Foodborne Illness Outbreaks
• March 3, 2026 - FDA Approves First Generic of Flovent HFA for Treatment of Asthma
• March 3, 2026 - FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s
• March 3, 2026 - FDA Announces Public Meeting on Dietary Supplement Innovation and the Scope of Dietary Ingredients

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

The FDA’s medical product safety reporting program for health professionals, patients and consumers, MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products.  The most recent alerts/recalls are here:

• Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
• UPDATE: FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication

Guidance Documents

• Questions and Answers on Biosimilar Development and the BPCI Act
• New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)
• Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection
• E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
• M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines
• New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers

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.

ICYMI!

FDA Office of Criminal Investigations

In 1991, The FDA Commissioner announced the establishment of an Office of Criminal Investigations (OCI) within FDA.  This law enforcement office was empowered to conduct and coordinate criminal investigations of violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Federal Anti-Tampering Act (FATA), other related acts, and applicable violations of United States Code 18 (Crimes and Criminal Procedures).

Webinars and Virtual Workshops

Town Hall – Clinical Decision Support Software, Final Guidance

Date: Wednesday, March 11, 2026; 1 - 2 p.m. ET

The FDA will host a town hall for industry and other interested parties to discuss updates to the Clinical Decision Support Software, Final Guidance, issued on January 6, 2026, and re-issued on January 29, 2026.

Public Meeting Exploring the Scope of Dietary Supplement Ingredients

Date: Friday, March 27, 2026; 9 a.m. - 3 p.m. ET

FDA’s Office of Dietary Supplement Programs (ODSP) invites stakeholders to participate in a public meeting to discuss the evolving landscape of dietary supplement ingredients and how recent scientific and technological advances are shaping the industry.

RISE Together: Data Sharing Across the Rare Disease Ecosystem

Date: Monday, March 30, 2026; 9 a.m. - 4:30 p.m. ET

This public workshop, co-convened by the Duke-Margolis Institute for Health Policy and the FDA Rare Disease Innovation Hub, is designed for all stakeholders in the rare disease community to explore data sharing as it pertains to informing development and regulatory review for rare disease therapies.  The workshop will focus on clarifying possible avenues for data sharing and the types of data that can be shared (e.g., safety information, real-world evidence, and deidentified patient data).  The workshop will also discuss: the promotion of data sharing practices and structures for facilitating data sharing among rare disease drug development stakeholders; examples of the impact of data sharing in regulatory submissions; a priori considerations for the collection and sharing of high quality data; some of the logistical and legal challenges encountered in data sharing; and whether there are ways that FDA might support data sharing, within the bounds of its authority.

Advancing Pediatric Cell and Gene Therapy Clinical Trials: Scientific, Ethical, Regulatory, and Practical Considerations

Date: Thursday, April 9, 2026; 9 a.m. - 4:30 p.m. ET

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) and the Alliance for Regenerative Medicine (ARM) are co-hosting a hybrid workshop on April 9, 2026, titled “Advancing Pediatric Cell and Gene Therapy Clinical Trials.”  The workshop will explore the issues surrounding clinical trials for cell and gene therapies (CGTs) in pediatric populations, particularly for diseases where earlier intervention may result in greater therapeutic benefit.  This includes conditions that affect both pediatric and adult populations, as well as diseases that occur primarily in children.

Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers

Date: Wednesday, April 15, 2026; 1 - 2:30 p.m. ET

Join the Small Business and Industry Assistance (SBIA) program for an informative webinar on the guidance, Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers.  Expanded access is a pathway for patients with serious or immediately life-threatening diseases or conditions to gain access to investigational drugs for treatment outside of clinical trials when no comparable or satisfactory alternative treatment options are available.  The primary goal of this event is to provide attendees with a comprehensive understanding of this pathway, including the regulatory requirements and FDA’s recommendations.

Achieving Data Quality and Integrity in Maximum Containment Laboratories — Nonclinical Course (FDA-UTMB Collaborative Education Program)

Day 1: Monday, April 20, 2026; 8:15 a.m. to 4:30 p.m. CDT

Day 2: Tuesday, April 21, 2026; 8:15 a.m. – 4:30 p.m. CDT

Day 3: Wednesday, April 22, 2026; 8:15 a.m. – 4:30 p.m. CDT

Day 4: Thursday, April 23, 2026; 8:15 a.m. to 4:30 p.m. CDT

Day 5: Friday, April 24, 2026; 8:15 a.m. – 12:15 p.m. CDT

The four and one-half day training program is offered annually utilizing expert faculty from the FDA, other government agencies, academia, and business and industry.  In-person attendees participate in laboratory activities conducted in mock Biosafety Level (BSL) 2, 3, and 4 training laboratories to emphasize the differences between biosafety levels and the complexity of conducting laboratory activities in a BSL4 laboratory environment.

Generic Drugs Forum (GDF) 2026

Day 1: Wednesday, April 22, 2026; 9 a.m. – 5 p.m. ET

Day 2: Thursday, April 23, 2026; 9 a.m. – 5 p.m. ET

The annual Generic Drugs Forum is a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generic medicines.  This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment programs, offering unparalleled insights and guidance.  Attendees will gain practical regulatory knowledge to enhance their applications, streamline the assessment process, and reduce cycles.  The forum's primary goal is to support prospective and current applicants in submitting complete and high-quality submissions, ultimately ensuring timely access to affordable medications that benefit public health.

FDA/MHRA/Health Canada Symposium: Regulatory Perspectives in Good Clinical Practice, Bioequivalence and Good Pharmacovigilance Practice

Day 1: Tuesday, June 2, 2026; 8:30 a.m. - 5:15 p.m. ET

Day 2: Wednesday, June 3, 2026; 8:30 a.m. - 5:15 p.m. ET

Day 3: Thursday, June 4, 2026; 8:30 a.m. - 5:15 p.m. ET

This symposium will highlight current and emerging topics of interest to the industry related to good clinical practice, bioequivalence, and good pharmacovigilance practice.  The event will bring together regulators, investigators, clinical researchers, clinical trial staff, sponsors, research organizations, service providers, pharmaceutical and biotechnology companies, academics, and patient advocacy groups.

Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop

Day 1: Monday, June 8, 2026; 8:30 a.m. - 4:30 p.m. ET

Day 2: Tuesday, June 9, 2026; 8:30 a.m. - 4:30 p.m. ET

The purpose of this annual public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.  FDA is seeking this input from the generic drug industry, academia, patient advocates, professional societies, and other interested parties, as it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs.  FDA will consider the information from the public workshop when developing its Fiscal Year (FY) 2027 Generic Drug User Fee Amendments (GDUFA) science and research priorities.  There is no cost to attend the event.  Interested parties will have two options to attend this public workshop.  Remote attendees may join virtually on Microsoft Teams via the “Join Event” links below.  Seating for in-person attendees will be limited to approximately 250 persons and will be available on a first come, first served basis.  Individuals can indicate their interest to attend in person by sending an e-mail to GDUFARegulatoryScience@fda.hhs.gov.  For parking and security information, please refer FDA’s visitor information page.

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

About Us

The Public 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, patients and patient advocacy organizations, consumer groups, trade associations, think tanks and academia, and other interested parties, in order to better inform our policy making process, identify policy hurdles or misconceptions, and create strategic collaborations.  For more information, please contact us at: PublicEngagement@fda.hhs.gov.  For patient specific inquiries, please contact us at: Patients Ask FDA.