Updates
Consumer Updates
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.
Before deciding whether your child should participate in a clinical trial, there’s a lot to know, including the risks and benefits. Let’s take a look.
Clinical Trials Can Help Improve Medical Treatments
Clinical trials are voluntary research studies conducted in people and designed to answer specific questions about the safety and/or effectiveness of new drugs, vaccines, and medical devices
Food Safety Tips for Healthy Holidays
Parties, family dinners, and other gatherings where food is served are all part of the holiday cheer. But the merriment can change to misery if food makes you or others ill.
Typical symptoms of foodborne illness are vomiting, diarrhea, and flu-like symptoms, which can start anywhere from hours to days after contaminated food or drinks are consumed.
The symptoms usually are not long-lasting in healthy people — a few hours or a few days — and usually go away without medical treatment.
Warning: Aspirin-Containing Antacid Medicines Can Cause Bleeding
The next time you reach for a nonprescription drug to treat your upset stomach or heartburn, consider whether you should use one of the many antacids that don’t have aspirin.
Why? Aspirin-containing medicines to treat heartburn, sour stomach, acid indigestion or upset stomach can cause stomach or intestinal bleeding, especially in some people, warns the FDA.
Aspirin is commonly used to reduce pain and fever. It is a nonsteroidal anti-inflammatory drug (NSAID) that can increase the risk of bleeding, including in the stomach and gastrointestinal tract (digestive tract).
Guidance Documents
Sameness Evaluations in an ANDA — Active Ingredients
This guidance is intended to assist applicants preparing an abbreviated new drug application (ANDA) by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug (RLD) as required under section 505(j)(2)(A)(ii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)(2)(A)(ii)) and FDA’s regulations in § 314.94(a)(5) (21 CFR 314.94(a)(5)).
M10 Bioanalytical Method Validation and Study Sample Analysis
The guidance describes recommendations for method validation for bioanalytical assays for nonclinical and clinical studies that generate data to support regulatory submissions, including the procedures and processes that should be characterized for chromatographic and ligand-binding assays that are used to measure the parent and active metabolites of drugs administered in nonclinical and clinical subjects.
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
UGA/FDA 9th Annual Medical Device Regulations Conference
November 15 - 16, 2022
Day 1: 7:30 AM - 5:00 PM ET
Day 2: 7:30 AM - 3:00 PM ET
University of Georgia (UGA) College of Pharmacy jointly developed the Medical Device Regulations Conference with FDA to facilitate understanding and collaboration between highly experienced professionals and technical experts from the FDA and industry on medical device issues. This conference carries out FDA’s mission to protect the public health and fulfill UGA’s educational and service missions.
Through a series of plenary and sessions, this conference will provide opportunities for attendees to learn about critical issues and current thinking in medical device regulations.
FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products
November 15, 2022; 12:00 PM - 4:30 PM ET
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a virtual patient-focused drug development listening meeting to better understand patient perspectives on gene therapy products, including cell-mediated gene therapies. This event is being held to meet an FDA commitment that is part of the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII).
FDA-CDER-CDRH, SNMMI, and MITA Workshop | Quantitative Brain Amyloid PET Imaging in Patients with Alzheimer’s Disease
November 17, 2022;8:30 AM - 5:05 PM ET
This workshop is intended for a diverse group of scientists, responsible for the evaluation of quantitative positron emission tomography (PET) measures of amyloid deposition in the brain in clinical trials and clinical use in patients with suspected or confirmed Alzheimer's disease.
The primary audience is meant to include leading academic experts, pharmaceutical companies, patient advocacy group, healthcare providers, clinicians and leading scientists from the US and abroad.
Medical Extended Reality: Applications and Challenges
November 17, 2022; 12:00 PM - 1:00 PM ET
This lecture will provide an overview of augmented and virtual reality technology and of the landscape of potential medical applications. The second part of the lecture will focus on regulatory science efforts to address evaluation challenges for using augmented and virtual reality in medicine.
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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