The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Action Levels for Cadmium in Processed Food Intended for Babies and Young Children." The draft guidance, when finalized, will establish action levels for cadmium in certain processed foods intended for babies and young children less than 2 years old. The draft guidance is intended to set achievable action levels that will help further reduce cadmium in the food supp

Original title: “Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability”

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of one additional draft chapter of a multichapter draft guidance for industry titled "Hazard Analysis and Risk-Based Preventive Controls for Human Food." This multichapter draft guidance, when finalized, will explain FDA's current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under FDA's regulation titled "Current Good Manufacturing Practice, Hazard An

Original title: “Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry." The guidance document provides answers to common questions that might arise about FDA's mandatory recall authority for cosmetics. It is intended to inform regulated industry about the Agency's current thinking on implementation of certain aspects, including the criteria, process, and expectations, for ma

Original title: “Questions and Answers Regarding Mandatory Cosmetics Recalls; Guidance for Industry; Availability”

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

Original title: “National Vaccine Injury Compensation Program; List of Petitions Received”

This notice publishes a list of HHS approved Medical Review Officers (MROs) certification entities. The most recent HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 10, 2023, (Oral Fluid) and February 1, 2024, (Urine), address the role and qualifications of MROs and HHS approval of entities that certify MROs.

Original title: “HHS Approval of Entities That Certify Medical Review Officers”

The Administration for Children and Families (ACF) is requesting an extension without changes of the form ACF-118: Child Care and Development Fund (CCDF) Plan Preprint for States/Territories for FFY 2025-2027 (Office of Management and Budget #: 0970-0114, expiration March 31, 2027), and an additional 3-year extension of the form ACF- 118: CCDF Plan Preprint for States/Territories for FFY 2028-2030. There are changes requested to the form ACF-118: CCDF Plan Preprint for States/Territories for FFY

Original title: “Proposed Information Collection Activity; Child Care and Development Fund Plan Preprint for States/Territories for Federal Fiscal Year (FFY) 2028-2030 (ACF-118) and extension of Child Care and Development Fund Plan Preprint for States/Territories for FFY 2025-2027”

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the public to comment on the information collection titled, "Division of Urban Indian Affairs (DUIA) Uniform Data System and Budget Formulation," Office of Management and Budget (OMB) Control Number 0917-0007. The IHS is requesting OMB to approve a reinstated collection.

Original title: “Request for Public Comment: 60-Day Notice for Reinstated Collection: Division of Urban Indian Affairs Uniform Data System and Budget Formulation”

FDA announces the launch of the Neuroscience Advancement and Innovation Nexus (NAIN), a new agency program aligned with the Trump Administration’s efforts to accelerate medical innovation and deliver breakthrough treatments.

Original title: “FDA Launches New Program to Advance Neuroscience Medical Product Development ”

The notice adds to growing concerns about the safety of knockoff weight loss drugs, which have remained popular despite FDA warnings and legal pressure from Eli Lilly and Novo.

Original title: “GLP-1 compounder issues recall for copycat Zepbound”

A new bipartisan bill aims to accelerate the development of rare disease treatments by making clinical trials faster, cheaper and more accessible to patients. The legislation would create networks of reusable clinical trial sites and allow more patients to participate in studies from their homes or ... A new bipartisan bill aims to accelerate the development of rare disease treatments by making clinical trials faster, cheaper and more accessible to patients. The legislation would create networks of reusable clinical trial sites and allow more patients to participate in studies from their homes or doctors' offices. When the trial ends, the infrastructure is dismantled and everyone goes their separate ways, even though many things are the same from trial to trial for a particular disease or type of treatment. The legislation aims to create a network of reusable clinical trial sites. "So you're not recreating the wheel every time you're trying to do a new drug," Auchincloss said in an interview with CNBC Cures. "You have a platform, and now you're just trying one thing after another." CNBC's Becky Quick interviews former FDA Commissioner Dr. Scott Gottlieb, Former Pennsylvania Republican Senator and rare disease advocate Rick Santorum, and Democratic Party Congressman Jake Auchincloss at the CNBC Cures Summit in New York City on March 3, 2026. Griffith said the bill would benefit patients beyond those with rare diseases, including residents of his southwest Virginia district who want to participate in studies of new treatments for black lung disease. Some of his constituents live a two-hour drive or longer from medical centers that typically host clinical trials. A new bipartisan bill aims to speed rare disease drug development by making clinical trials faster, cheaper and more accessible to patients.

Original title: “New bipartisan bill aims to speed up clinical trials for rare disease treatments”

Agreement enables procurement in over 50 countries

Original title: “ViiV and Axmed expand access to HIV medicines”

The $100,000 H-1B visa fee has significantly affected who biopharma companies hire, according to two experts. It’s not the only program adjustment affecting foreign-born job seekers’ odds of working in the U.S.

Original title: “As H-1B visa changes keep coming, biopharmas adjust hiring approach”

Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 10887: Protecting Consumer Access to Generic Drugs Act of 2026”

The recurrence of violations at multiple sites led the FDA to conclude that Baxter management must improve its oversight and control of manufacturing.

Original title: “FDA accuses Baxter leaders of ‘inadequate’ oversight after finding GMP failings”

Just one-third of patients prescribed new medicines filled them within 30 days, with a new report from the Institute for Clinical and Economic Review and West Health suggesting that cost is the problem.

Original title: “Drug prices climb past $250K as US patients balk at the pharmacy”

The Department of Health's adoption of affordable generic Risdiplam for Spinal Muscular Atrophy marks a major victory for patient access and public health Spinal Muscular Atrophy (SMA) is a rare, life-threatening genetic disorder that progressively weakens muscles, severely impairing both mobility and respiratory function. Although a complete cure remains elusive, Risdiplam is currently available as a pharmaceutical intervention capable of significantly decelerating disease progression. Timely administration of this medication is critical for enhancing patients’ quality of life and longevity. Roche’s branded therapeutic equivalent, Evrysdi (Risdiplam), costs about ₹6.2 lakh per bottle. Conversely, Natco’s generic version costs only ₹15,900 per bottle. Since a single bottle typically lasts 12 days, Natco’s monthly expenditure is about ₹30,000 (though actual costs may vary based on the patient’s age, dosage, and volume used). The availability of scientifically validated, universally recognised generic pharmaceuticals at lower cost is a major benefit for SMA patients and their families. Consequently, the Department of Health must disregard these unfounded media campaigns and steadfastly advance this decisive, patient-centric initiative. Dr B Ekbal is a former professor of neurosurgery and a public health activist. When authorised enterprises such as Natco introduce generic formulations, they must legally and scientifically demonstrate bioequivalence, proving that the drug enters the bloodstream in a manner comparable to the branded original. Under the Drugs and Cosmetics Act, regulatory approval for any generic pharmaceutical is granted only after successful completion of rigorous bioequivalence studies.

Original title: “Why recognising a generic drug for Spinal Muscular Atrophy is significant - The Week”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Regulatory Considerations for Prescription Drug Use-Related Software." This final guidance describes FDA's application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug product or a prescription drug-led, drug-device combination product that is assigned to the Center for Drug Ev

Original title: “Regulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availability”