Updates
Spotlight!
Rumor Control: Learn and Share FDA Facts
The growing spread of rumors, misinformation and disinformation about science, medicine, and the FDA, is putting patients and consumers at risk. We’re here to provide the facts.
Consumer Updates
Accidental Exposures to Fentanyl Patches Continue to Be Deadly to Children
Accidental exposure to medication is a leading cause of poisoning in children. Young children, in particular, have died or become seriously ill after being exposed to a skin patch containing fentanyl, a powerful opioid pain reliever. If you suspect that a child has been exposed to a fentanyl patch, call 911 and seek emergency medical help immediately.
The FDA urges parents and caregivers to take precautions and make sure that these patches are stored, used and disposed of properly. Below are some ways to reduce the risk of exposure and safely dispose of these patches – and what to do if a child is exposed to a fentanyl patch.
Have You Given Blood Lately?
Every day, hospitals throughout the U.S. transfuse blood or blood components, such as platelets, to save the lives of people who are in motor vehicle accidents, and victims of fires and other emergencies.
Blood is also required for many people with life-threatening illnesses and others undergoing routine surgeries. According to the Centers for Disease Control (CDC), blood centers and hospitals in the U.S. collect and transfuse millions of units of blood each year.
In fact, every two seconds, someone in America needs blood, according to the American Red Cross (ARC).
Guidance Documents
Small Entity Compliance Guide: Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation
This guidance document is intended to help small entities, including farms and small businesses, comply with the requirements of the Food Traceability Rule as established in 21 CFR part 1, subpart S. The regulations are binding and have the full force and effect of law.
Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations
The purpose of this guidance is to assist industry in developing data and obtaining information needed to support approval of drug products in pediatric populations. This guidance addresses selected clinical, scientific, and ethical issues regarding the development of drugs for pediatric use when such drugs are subject to the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act (BPCA).
Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act
This guidance is intended to assist industry developing drug products to comply with the pediatric study requirements under the Pediatric Research Equity Act (PREA), and to describe the process for qualifying for pediatric exclusivity and the protections that pediatric exclusivity offers under the Best Pharmaceuticals for Children Act (BPCA).
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!
Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies
By: Robert M. Califf, M.D., Commissioner of Food and Drugs and Hilary Marston, M.D., M.P.H., Chief Medical Officer
The U.S. Department of Health and Human Services is planning for the federal Public Health Emergency for COVID-19 declared under the Public Health Service Act to expire on May 11, 2023. We’ve arrived at this point because of the U.S. government’s historic investments and our collective efforts to mitigate COVID-19’s worst impacts. While the HHS public health emergency is ending, COVID-19 remains a high priority and the FDA will remain engaged with numerous activities to protect and promote public health.
Webinars and Virtual Workshops
FDA’s Global Substance Registration System (GSRS) Unique Ingredient Identifiers (UNIIs) uniquely define substances in FDA-regulated products
June 8, 2023; 12:00 PM - 1:00 PM ET
FDA’s Global Substance Registration System (GSRS) makes it possible for substances to be defined by standardized, scientific descriptions that are now used by our partners worldwide. All substances are assigned Unique Ingredient Identifiers (UNIIs). This presentation will highlight UNIIs, the various types of substances captured, and briefly highlight types of data linked to records.
Visit webpage for registration options
2023 FDA Science Forum
June 13 - 14, 2023
Day 1: 9:00 AM - 3:30 PM ET
Day 2: 9:00 AM - 2:00 PM ET
The Forum offers an exciting opportunity for the public to view the unique scientific research and collaborative efforts of FDA’s 11,000 scientists. You'll get a chance to see first-hand how FDA's researchers are using novel science and technologies to inform FDA’s regulatory decision-making — and drive innovation.
FDA’s Science Forum welcomes the public, industry, academia, patient advocates, sister agencies, and current and potential collaborators to join us virtually and learn about the critical contributions that FDA's regulatory science makes to product quality and safety.
Visit webpage for registration options
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.
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