FDA

The FDA is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their long-term use. https://xmrrwallet.com/cmx.plnkd.in/ec7-E5ia These changes follow a public advisory committee meeting in May that reviewed data showing serious risks—such as misuse, addiction, and both fatal and non-fatal overdoses—for patients who use opioids over long periods.

FDA’s Center for Tobacco Products is requesting nominations by Aug. 25, 2025, for voting members to serve on the Tobacco Products Scientific Advisory Committee (TPSAC). Individuals may self-nominate or be nominated by any interested person or organization. Learn how to submit a nomination: https://xmrrwallet.com/cmx.plnkd.in/eqUQbFfy

Today, we released our Expanded Decision Tree (EDT) chemical toxicity and risk screening tool that advances the agency’s commitment to transparency and enhancement of the food chemical safety program. The tool provides a consistent, systematic, and science-based approach to support evaluation of the safety of chemicals in food based on their structure and estimated toxicity. https://xmrrwallet.com/cmx.plnkd.in/exPQb4WW The EDT was evaluated through external peer-review, marking a significant milestone in its development. The agency will engage stakeholders and the public for further feedback on the tool.

The FDA has published a final question-and-answer guidance to help develop antibacterial drugs for serious bacterial diseases, particularly those caused by drug-resistant organisms. Key highlights: • Provides regulatory flexibility for sponsors developing new antibacterial therapies • Addresses urgent need for treatments for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia, complicated urinary tract infections, and complicated intra-abdominal infections caused by antimicrobial drug-resistant organisms • Updates clinical trial design approaches, including add-on superiority trials This guidance represents FDA's commitment to supporting innovation in the antibacterial drug development space. Read the full guidance: https://xmrrwallet.com/cmx.plnkd.in/eN7VWSV5

FDA has issued a Federal Register notice announcing a Tobacco Products Scientific Advisory Committee (TPSAC) meeting on October 7, 2025. https://xmrrwallet.com/cmx.plnkd.in/eb4fqt_6 The meeting will discuss the renewal of modified risk granted orders issued to Philip Morris Products S.A. for the following products: ➡️ Marlboro Amber HeatSticks  ➡️ Marlboro Green Menthol HeatSticks  ➡️ Marlboro Blue Menthol HeatSticks ➡️ IQOS 2.4 System Holder and Charger ➡️ IQOS 3.0 System Holder and Charger The TPSAC meeting will be open to the public and held at FDA’s White Oak Campus in Silver Spring, MD. Additionally, the public can attend via webcast, and it will be captioned and recorded. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

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.