FDA

Today, the FDA is taking a bold step to protect Americans from dangerous, illegal opioids by recommending a scheduling action to control certain 7-hydroxymitragynine (also known as 7-OH) products under the Controlled Substances Act (CSA). https://xmrrwallet.com/cmx.plnkd.in/euUhpd-3 This recommendation follows a thorough medical and scientific analysis by the FDA and is one of several efforts to address the agency’s concerns around the growing availability and use of 7-OH opioid products. There are no FDA-approved 7-OH drugs, 7-OH is not lawful in dietary supplements, and 7-OH cannot be lawfully added to conventional foods.

Reminder: Monday, August 4, we will host a public meeting to discuss recommendations for the reauthorization of the Medical Device User Fee Amendments for fiscal years 2028 through 2032 (MDUFA VI). Find out more and register today. https://xmrrwallet.com/cmx.plnkd.in/gsDX4HrQ

The FDA is excited to continue its national listening tour meeting directly with pharmaceutical and biotech CEOs. These forums are part of a new initiative to gather direct input from biotechnology and pharmaceutical leaders on how the FDA can modernize its regulatory framework to better support innovation and patient access to safe and effective therapies.       The FDA’s next stops are Atlanta, GA and Raleigh, NC. If you are a pharmaceutical or biotech CEO, register today! https://xmrrwallet.com/cmx.plnkd.in/eR25grHc

On July 17, 2025, the FDA hosted the FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women. You can view here: https://xmrrwallet.com/cmx.plnkd.in/eP6sj9xE In follow-up to this meeting, the FDA is opening a docket to allow for submission of public comments on the risks and benefits related to menopause hormone therapy, including data that could support updates to the labeling of such products. This request is part of the FDA’s effort to understand various perspectives on these safety considerations and the use of hormone therapy for menopause-related conditions in clinical practice. Comments must be received no later than 11:59 pm ET, Sept. 24, 2025, at https://xmrrwallet.com/cmx.plnkd.in/efPTHnzK. The FDA will not reply individually to responders but will consider all comments submitted by the deadline.

The FDA has issued a revised draft guidance addressing aluminum contamination in small volume parenteral (SVP) products used for parenteral nutrition. https://xmrrwallet.com/cmx.plnkd.in/eisk-t7U Key highlights:  Small volume parenteral (SVP) products for parenteral nutrition (PN) are important for people who need intravenous (IV) nutrition Toxicity from aluminum in SVPs poses risks to patients with immature or impaired kidneys, such as neonates and chronic kidney failure patients, who need prolonged treatment with PN  Recommended limit: ≤5 mcg/kg/day total aluminum exposure from all PN components  This guidance emphasizes the importance of accounting for aluminum from multiple PN products and provides clearer recommendations for acceptable aluminum concentrations. Companies must consider how their individual products contribute to the total recommended limit. 

The FDA is advising consumers not to eat and restaurants and food retailers not to serve or sell and to dispose of these frozen, raw, half-shell oysters that were shipped to distributors in AZ, CA, CO, MT and UT, and may have been distributed to other states as well. https://xmrrwallet.com/cmx.plnkd.in/ekCRR7QR

Recalled Ready-to-Eat (RTE) foods are past shelf life and are no longer available for sale. https://xmrrwallet.com/cmx.plnkd.in/e2uaB3bq CDC has declared the outbreak over & FDA’s investigation is complete.

The FDA has released the Regulatory Accelerator, a set of resources that supports the FDA’s priority to accelerate cures and treatments by helping digital health innovators bring safe and effective medical devices to market. https://xmrrwallet.com/cmx.plnkd.in/egdUqusK Check out a visual guide to FDA resources, engagement opportunities, and guidances available throughout the process of bringing medical device software to market; learn about early orientation meetings with the FDA on marketing submissions; and use the Medical Device Software Guidance Navigator to help identify guidances that may be applicable to your device across the development lifecycle. 

📢 FUNDING OPPORTUNITY: FDA Research Cooperative Agreement  The FDA Oncology Center of Excellence (OCE) has announced a Request for Applications to support Applied Regulatory Science Research to Evaluate Cardiotoxicity of Oncology Therapeutics. https://xmrrwallet.com/cmx.plnkd.in/eBCSGGg4 Key Details:   • Focus: Improving detection and monitoring of cardiotoxicity associated with cancer therapies   • Aligns with FDA OCE's mission to develop safe, effective cancer treatments while addressing cardiovascular risks   • Opportunity for researchers to contribute to critical patient safety advancements Why This Matters: As cancer survival rates improve, the long-term cardiac effects of oncology therapeutics have become increasingly important. This funding supports research that could potentially impact clinical practice and regulatory decision-making. Application Deadline: August 8, 2025  If your organization conducts research in cardio-oncology or regulatory science, this presents a significant opportunity to advance the field while addressing a critical need in cancer care. #RegulatoryScience #CardioOncology #CancerResearch #FDA #ResearchFunding #ClinicalResearch 

Under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration and Department of Agriculture are accelerating efforts to address concerns around ultra-processed foods and America's epidemic of diet-related chronic diseases. https://xmrrwallet.com/cmx.plnkd.in/ezuutpMa Tomorrow, the agencies will announce a joint Request for Information (RFI) to help establish a uniform definition for ultra-processed foods—a critical step that will allow us to better address the problem and empower consumers to make informed choices.