The United States Food and Drug Administration (FDA) has issued its weekly regulatory update for stakeholders. You can read the FDA regulatory update for stakeholders below.
September 6, 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.
Want to be better prepared for emergencies? Check out these tips.
Emergencies and disasters such as hurricanes, floods, lightning storms, earthquakes, and fires can affect everyone from people who rely on medical devices, to companies that manufacture medical devices, to shipping and delivery operators who get medical devices to our doors.
Should You Give Kids Medicine for Coughs and Colds?
Although most colds in children don’t cause serious complications, they can cause stress and worry in parents and caregivers. It’s understandable that you might want to give your child medicine to treat a cold. But most children will get better on their own, and cough or cold medicine will not change the natural course of a cold or make it go away faster.
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.
Should Your Child Participate in a Clinical Trial?
Clinical trials help provide reliable evidence needed when studying medical products to diagnose, prevent, treat, and sometimes even cure, childhood diseases. Children who participate in these research studies may also potentially benefit from the medical products under investigation.
Healthy Breakfasts for Kids: It's All About Balance
A healthy breakfast is a must for kids. Skip it and your kids will be playing nutritional catch-up for the rest of the day.
Growing bodies and developing brains need regular, healthy meals. According to the Academy of Nutrition and Dietetics, studies show that school children who eat breakfast perform better in the classroom.
Medicines for Your Pet: What's The Difference Between FDA-approved & Pharmacy-compounded Drugs?
If you’ve ever had to give your pet a dose of medicine, you know it might turn into a battle. While many animals will gladly take any pill hidden in cheese, peanut butter or other treat, some do not enjoy the process and will refuse to take a pill. Additionally, some species are unable to take pills at all.
FDA is issuing this draft guidance to communicate when and what methods could be used to collect and submit patient preference information (PPI) across the total product life cycle. This will include helping explain when PPI may be helpful, and in what context.
This final guidance recommends steps manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products.
This Bioresearch Monitoring Technical Conformance Guide provides current FDA specifications, recommendations, and general considerations for preparing and submitting Clinical Study-Level Information, Subject-Level Data Line Listings by Clinical Site, and a Summary-Level Clinical Site Dataset that are used by the Center for Drug Evaluation and Research (CDER) for planning of Bioresearch Monitoring (BIMO) inspections in electronic format for new drug applications (NDAs), biologics license applications (BLAs), and NDA or BLA supplemental applications containing clinical data that are regulated by CDER. It also applies when these data and information are submitted under certain investigational new drug applications (INDs) in advance of a planned NDA, BLA, or supplemental submission.
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 In Your Day: Hurricane Preparedness
Discover ways to stay safe before, during and after any severe weather event in this latest installment of FDA In Your Day.
Join us for the 2024 Advancing Generic Drug Development Workshop! FDA experts will demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. Dissect complex scientific challenges in ANDAs alongside FDA experts, and gain insights into GDUFA III progress, GDUFA science and research on complex products and scientific issues to product-specific guidance development, pre-ANDA and ANDA meeting discussions.
On Tuesday, September 24, CDER's Office of Communication, Division of Drug Information (DDI) will host a webinar titled: FDA Drug Topics: The Bad Ad Program. There are several innovative opportunities to collaborate with the FDA. This webinar will focus in on the FDA's Bad Ad Program. It will provide an overview of prescription drug promotion and its regulation along with information on how healthcare professionals can report potentially false or misleading prescription drug promotion to the FDA.
The FDA will host a stakeholder webinar on Thursday, October 10, 2024, at 1:00 pm ET to provide an overview of the recently released draft guidance outlining new, voluntary targets for sodium reduction in foods and the preliminary assessment of progress 2010 - 2022.
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.
September 6, 2024
