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September 2, 2022
As you and other public health advocates work on the front lines, we want you to know that we recognize your concerns about protecting the safety of yourselves, your families, and others you care for. The FDA's work is critical to ensuring the health and safety of the American public at any time, but is magnified during public health emergencies.
Protecting the public's health, using science to guide our decisions, and facilitating access to critical medical products continue to be top priorities for the FDA.
FDA's Overdose Prevention Framework Aims to Prevent Drug Overdoses and Reduce Death
By: Robert M. Califf, M.D., Commissioner of Food and Drugs (pictured below)
In 2021, a record number of Americans – more than 107,000 – died from drug overdoses. While the loss of human life alone is staggering, we know that the effects of the drug overdose crisis are even broader, including enormous individual and societal costs as people and families grapple with substance use disorder (SUD). Due to this unfortunate reality, in 2017 the opioid crisis was determined to be a public health emergency, which to this day is still in effect.
Today's drug overdose crisis is multifaceted and has evolved beyond prescription opioids. Illicit opioids, largely driven by fentanyl and its analogues, have become key contributors. Other controlled substances, including benzodiazepines and stimulants (particularly methamphetamine), also are being used in combination with opioids.
Using A Whole-Of-Governments Approach to Combating Illicit Health Products
By: Cathy Hermsen, Assistant Commissioner for Criminal Investigations and Ritu Nalubola, Director of the FDA's Europe Office
Criminal networks are increasingly sophisticated and capable of exploiting regulatory, legal, and other gaps to ship and/or transship illicit and potentially dangerous health products to the U.S., putting patients at risk.
The variety and scope of the illicit products that the FDA is witnessing, entering our international mail facilities, has been staggering. The agency has seen medications to treat cancer or chronic diseases such as high blood pressure or diabetes, prescription medical devices, and veterinary drugs.
Beware of Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation
If you use an ultraviolet wand to disinfect and kill germs — or are thinking about it — be aware that certain brands may produce unsafe levels of radiation and should not be used.
The FDA issued a safety communication warning consumers that certain UV wands may cause injury to the skin, eyes, or both after a few seconds of use. The safety communication lists the brands that should not be used, details the FDA's actions, and provides recommendations for consumers.
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, says the FDA.
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.
As with other meals, it's a good idea for your kids (and you) to eat a healthy balance of fruits and vegetables, proteins, grains and dairy — not just for breakfast but throughout the day.
The purpose of this guideline is to provide recommendations for, and promote international harmonization of, the use of pediatric extrapolation to support the development and authorization of pediatric medicines. Harmonization of the approaches to pediatric extrapolation should reduce the likelihood of substantial differences between regions.
This guideline provides recommendation to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of a therapeutic product. A consistent approach will reduce uncertainty for pharmaceutical industry to meet the requirement of multiple regulatory agencies and lead to more efficient utilization of resources.
This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products.
This guideline presents a discussion of elements for consideration during the validation of analytical procedures included as part of registration applications submitted within the ICH member regulatory authorities. Q2(R2) provides guidance and recommendations on how to derive and evaluate the various validation tests for each analytical procedure. This guideline serves as a collection of terms, and their definitions.
The conference will highlight how stakeholders can protect patients from unsafe, ineffective, and poor-quality compounded drugs while preserving access to compounded drugs for patients who have a medical need for them.
The conference will feature subject matter expert presentations, interactive sessions, and roundtable conversations. Stakeholders in the compounding community will share their perspectives. Attendees will be able to engage with FDA, learn about emerging trends, and gain quality compounding insights.
The FDA Scientific Computing Board is a group of scientists and IT specialists at FDA who advocate for scientific computing needs, and requirements to advance FDA's scientific and regulatory mission. The 10th annual Scientific Computing Days symposium is a conference promoting the latest advances in scientific computing technologies.
In 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) amended the FD&C Act to require that each person (including repackers and labelers) who registers with FDA under section 510 of the FD&C Act with regard to a human or animal drug must report annually to FDA the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.
In this webinar, FDA will provide an overview of the drug amount reporting program, including discussions of how FDA uses the drug amount report data and who reports and how (with examples and demonstrations).
FDA regulatory science played a leading role in the evaluation and the development of state-of-the-art quality control methods for the new generation of polio vaccines. The presentation will discuss the evolution of vaccines against poliomyelitis driven by the change in disease epidemiology, socio-economic circumstances, and advances in biotechnology.
FDA, the U.S. Patent and Trademark Office (USPTO), the Silicon Valley PTO, and Biocom California will hold a free virtual meeting in which participants can hear about the intricacies that biotech and medtech independent inventors and startups face when seeking regulatory approval from the FDA and securing intellectual property rights from the USPTO.
The conference will emphasize the role of robust pharmaceutical quality systems in ensuring state of control. Key themes will include leveraging the digital and automation revolution, contamination control strategy, latest FDA CGMP trends, how to respond effectively to FDA 483s, assuring supply chain reliability, the facility and equipment lifecycle, ICH update, and leveraging beneficial manufacturing innovations.
The Acute Pain Pathways study was launched in collaboration with and supported by the FDA to understand the trajectories of pain and treatments experienced by a diverse group of opioid naïve patients who are prescribed an opioid analgesic for acute pain. In this talk, Dr. Jeffery will describe the study and present some preliminary results drawing from participants' reports of their pain severity and resolution, treatments used, satisfaction with care, and opioid handling and safety.
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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