Michael Felberbaum

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… Today, we announced the release of a new prevention strategy aimed at combating the contamination of fresh and frozen berries with enteric viruses, such as Hepatitis A Virus and Norovirus. fda.gov/food/new-era-s… Today, we released the IT Operating Plan for Fiscal Years 2024 - 2027, which provides the agency’s strategic blueprint for technology and data in support of advancing public health. fda.gov/media/185225/d… On Thursday, we announced a public workshop, Optimizing Pregnancy Registries. fda.gov/drugs/news-eve… Today, we issued the @FDADeviceInfo 2024 Annual Report. fda.gov/about-fda/cdrh… Today, we issued a notice in the Federal Register announcing a virtual public workshop entitled "Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development." fda.zoomgov.com/webinar/regist… On Thursday, we issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent and mitigate potential shortages, and solutions to strengthen the domestic supply chain and address these vulnerabilities.  fda.gov/medical-device… On Thursday, we announced an early alert about Fresenius Kabi USA recommending certain software versions of the Ivenix Infusion System be updated related to a potentially high-risk device issue. fda.gov/medical-device… On Thursday, we approved Lumakras (sotorasib) with Vectibix (panitumumab) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. fda.gov/drugs/resource… On Thursday, we granted traditional approval to Calquence (acalabrutinib) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). fda.gov/drugs/resource… On Wednesday, we issued an order to revoke the authorization for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition that requested the agency to review whether the Delaney Clause applied. fda.gov/food/hfp-const… On Wednesday, we requested comments about the FDA’s Digital Health Advisory Committee discussion during the meeting in November 2024 related to Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical Devices. fda.gov/advisory-commi… On Wednesday, @FDAanimalhealth released a request for information (RFI) soliciting comments from the public, particularly veterinarians, related to the use of cannabis-derived products (CDP) in animals. fda.gov/animal-veterin… On Wednesday, the Rare Disease Innovation Hub (the Hub) released its Strategic Agenda, which outlines the actions the Hub plans to undertake during its first year with extensive involvement from the rare disease community, while also addressing questions about the ultimate structure and programs of the Hub. fda.gov/media/185144/d… On Tuesday, we published the Animal Welfare, Testing and Research of FDA-Regulated Products Consumer Update. fda.gov/consumers/cons… On Tuesday, we issued a Request for Information (RFI) on manufacturing processes and ingredients used to make certain dairy products which, for purposes of the RFI, we refer to as high-protein yogurt, Greek yogurt, or Greek-style yogurt (also collectively referred to as "high-protein yogurt" in this RFI). federalregister.gov/public-inspect… Lastly, we published a Spotlight on CDER Science featuring CDER's work with international regulators to develop a methodology, the Carcinogenic Potency Categorization Approach (CPCA), that uses the chemical structure of a nitrosamine impurity to recommend acceptable intake (AI) limits by assignment to 1 of 5 predicted potency categories reflecting carcinogenic risk. fda.gov/drugs/spotligh…

Today, FDA authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. fda.gov/news-events/pr…

COMING UP: Join us for a virtual press conference to discuss the FDA’s proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or non-addictive by limiting the level of nicotine in those products. youtube.com/live/3-AY3XEIt…

Today, FDA issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products. fda.gov/news-events/pr…

Today, the FDA is issuing an order to revoke the authorization for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition that requested the agency to review whether the Delaney Clause applied. fda.gov/food/hfp-const…

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… Today, we issued a Request for Information (RFI)on industry practices related to poppy seeds. fda.gov/food/hfp-const… Today, @FDAanimalhealth issued a Dear Veterinarian letter alerting practitioners to the possibility of burns associated with the use of Megadyne grounding pads in animal surgical patients. fda.gov/animal-veterin… On Monday, we published the FDA Voices, “Vaccines for COVID-19: A Personal Reflection,” by Robert M. Califf, MD, Commissioner of Food and Drugs. fda.gov/news-events/fd… We also published the blog, “FDA Spearheads Global Efforts on Informal Markets and Substandard/Falsified Medical Products.” fda.gov/international-… Lastly, we, along with @HSI_HQ, and @CBPNorthAmerica announced the seizure of more than 628,000 unauthorized e-cigarette products from a warehouse in Miami. fda.gov/tobacco-produc…

ICYMI, a live replay available via the same link!

Today, we are announcing an important step to provide nutrition information to consumers by proposing to require a front-of-package nutrition label for most packaged foods. This proposal plays a key role in our nutrition priorities, which are part of a government-wide effort in combatting the nation’s chronic disease crisis. fda.gov/news-events/pr…

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… Today, we issued a notice in the Federal Register with our determination that 35 food contact notifications (FCNs) related to per- and polyfluoroalkyl substances (PFAS) are no longer effective. fda.gov/food/hfp-const… Yesterday, we issued a safety alert for restaurants, retailers, and consumers in Oregon and Washington. The alert advises against consuming, selling, or serving shellstock oysters harvested from Dec. 2 to Dec. 17, 2024, by Ruco’s Shellfish (WA-1995-SS) from a specific area of Hammersley Inlet, WA. This advisory is in response to a recall initiated by Washington State, following a norovirus outbreak associated with these oysters. fda.gov/food/alerts-ad… On Tuesday, we issued the latest medical device early alert for solution sets, fluid delivery sets, and single use blood circuits. fda.gov/medical-device… On Monday, we announced a virtual public meeting that will be held on Jan. 30, 2025, 11 a.m.-12 p.m. ET to share the Center for Devices and Radiological Health’s recent Real-World Evidence program updates and activities. fda.gov/medical-device… Also on Monday, we unveiled an Idea Lab, as part of the Home as a Health Care Hub initiative, to help innovators, providers, and patients reimagine the home as an integral part of the health care system. The Idea Lab includes a virtual reality prototype, named Lilypad™, which will give users an immersive experience inside various affordable homes of representative people living with diabetes. fda.gov/medical-device…

Today, we published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important devices for patient care that are used to estimate the amount of oxygen carried in the blood – across the range of skin pigmentation. fda.gov/news-events/pr…

Today, we issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle.  fda.gov/news-events/pr…

Today, we issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality. fda.gov/news-events/pr…

Today, we issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials. fda.gov/news-events/pr…

Today, @US_FDA announced the availability of a draft guidance for industry titled “Study of Sex Differences in the Clinical Evaluation of Medical Products.” Read it to learn why analyzing sex-related differences in medical product response matters. fda.gov/regulatory-inf…

Check out the latest FDA Roundup, our at-a-glance summary of agency updates: fda.gov/news-events/pr… Today, we posted warning letters sent to six firms selling unapproved drugs that claim to treat and control seizures in dogs and cats. fda.gov/animal-veterin… We also issued the draft guidance, “Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies.” fda.gov/regulatory-inf… Additionally, we issued the draft guidance, “Developing Drugs for Optical Imaging.” fda.gov/regulatory-inf… Yesterday, we issued the final guidance, “Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children.” fda.gov/regulatory-inf… We also issued the final guidance, “Guidance for Industry (GFI) #294: Animal Food Ingredient Consultation (AFIC)”. fda.gov/regulatory-inf… Additionally, we issued the draft guidance, “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway”. fda.gov/regulatory-inf… We also issued the draft guidance, “Study of Sex Differences in the Clinical Evaluation of Medical Products”. fda.gov/regulatory-inf… We also issued the draft guidance with the Office for Human Research Protections, “Considerations for Including Tissue Biopsies in Clinical Trials.” fda.gov/regulatory-inf… We also issued four draft guidances and two final guidances on human cells, tissues, and cellular and tissue-based products (HCT/Ps) regarding donor eligibility determinations, which includes: Recommendations for Determining Donor Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). fda.gov/regulatory-inf… Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). fda.gov/regulatory-inf… Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). fda.gov/regulatory-inf… Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). fda.gov/regulatory-inf… Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). fda.gov/regulatory-inf… Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). fda.gov/regulatory-inf… Additionally, we issued the final guidance, “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act”. fda.gov/regulatory-inf… Lastly, on Monday in conjunction with the @NIH we announced that registration is open for the FDA-NIH Rare Disease Day 2025 meeting. reg.eventmobi.com/fdanihrdd2025 On Friday, we submitted its report to Congress, “Diversity Action Plans Summary: FY 2023 and FY 2024,” which summarizes the diversity plans the agency received during that timeframe. fda.gov/media/184768/d…

Keeping track of when, how and why you use medications is important for your health and safety. A list can be a lifesaver, especially during an emergency. fda.gov/consumers/cons…

Please join me in thanking Dr. Bumpus for her service, her good humor and her leadership. She has had a real and positive impact on this agency and its ability to protect the health of the American public.

Today, we announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products. This proposed rule, if finalized, will help protect consumers who use talc-containing cosmetic products from harmful exposure to asbestos. fda.gov/news-events/pr…

Today, we approved the first generic for an injectable GLP-1 used to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise. fda.gov/news-events/pr…

Today, we approved a medication for the treatment of moderate to severe obstructive sleep apnea in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity. fda.gov/news-events/pr…