The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance includes three documents: a guidance, a template, and a technical specification document. The guidance provides the rationale and recommen

Original title: “M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability”

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that expl

Original title: “Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability”

This document corrects technical and typographical errors in the proposed rule that appeared in the April 14, 2026 Federal Register titled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; and Other Policy Changes."

Original title: “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; and Other Policy Changes; Correction”

Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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 8943: To amend title XVIII of the Social Security Act to prohibit payments for graduate medical education costs attributable to individuals who are not citizens or nationals of the United States under the Medicare program.”

Referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and Workforce, 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 4120: Supporting the Mental Health of Educators and Staff Act of 2025”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 4468: Supporting the Mental Health of Educators and Staff Act of 2026”

The ‘Rare disease therapies ... disease therapies and make them more affordable, the MHRA said. ... Medicines and Healthcare Regulatory Agency highlighted that rules that government clinical trials and drug approvals were designed around common diseases, rather than rare conditions ... The Medicines and Healthcare products Regulatory Agency (MHRA) has asked for views on plans to speed up access to rare disease treatments... The ‘Rare disease therapies regulatory framework’ would incorporate a compressed regulatory pathway, aimed to reduce the cost of developing rare disease therapies and make them more affordable, the MHRA said. ... Medicines and Healthcare Regulatory Agency highlighted that rules that government clinical trials and drug approvals were designed around common diseases, rather than rare conditions ... The Medicines and Healthcare products Regulatory Agency (MHRA) has asked for views on plans to speed up access to rare disease treatments. Yet fewer than 5% of rare diseases currently have an approved treatment. “Developing therapies for rare diseases is genuinely hard. Patient numbers are small, scientific understanding is often limited, and the financial case for investment is weak. “The regulatory rules that govern clinical trials and drug approvals were designed around common diseases — they assume large patient populations and the kind of definitive clinical trial data that is simply impossible to generate when a condition affects approximately one in 50,000 or fewer people,” the statement added. The Medicines and Healthcare products Regulatory Agency (MHRA) has asked for views on plans to speed up access to rare disease treatments. A statement published by the MHRA on 21 May 2026 said its proposed ‘Rare disease therapies regulatory framework’ would incorporate a compressed regulatory pathway, which was “expected to reduce the cost of developing […] “Central to the proposal is a new investigational marketing authorisation, which would combine clinical trial approval with a progressive route to market authorisation approval,” the statement said. “This means that where there is limited evidence, patients could gain access to innovative treatments earlier, subject to approval by the National Institute for Health and Care Excellence (NICE) on NHS use.” · The MHRA announced its commitment to reform rare disease therapies in November 2025.

Original title: “MHRA asks for views on rare disease therapy plans - The Pharmaceutical Journal”

Because of these small populations, rare diseases often face unique – and some respects potentially more significant – hurdles in implementing clinical trials, thus delaying development of novel therapies and leaving significant clinical unmet needs. From a patient perspective, this means fewer, if any, available treatment ... Because of these small populations, rare diseases often face unique – and some respects potentially more significant – hurdles in implementing clinical trials, thus delaying development of novel therapies and leaving significant clinical unmet needs. From a patient perspective, this means fewer, if any, available treatment options, that can often only be received at a limited number of specialised research centers. Current standards of care for the majority of those diagnosed is heterogeneous,and may include multiple rounds of chemotherapy and resective surgery, and survival rates remain low in patients with metastatic disease. This intense multimodal treatment has long-term adverse effects, particularly on patient quality of life (QOL)6. This alone necessitates the need for new and novel therapeutics, and thus demands acceptance of new strategies in innovative clinical trials where data supporting strong efficacy and acceptable safety profiles meet patients’ needs in rare diseases. In the case of osteosarcoma, where patient numbers are small and treatment options remain limited, patient and carer perspectives are particularly valuable in shaping decisions, ranging from what constitutes an acceptable burden of treatment to how trial eligibility criteria should reflect real-world experience. The need for regulatory flexibility in consideration of novel clinical trial design · In recent years, modest progress has been made in other rare disease settings by regulatory agencies practicing flexibility for clinical trials. In oncology alone, between 2002 and 2021, 176 new therapies were approved by the FDA based on single-arm trials, 116 of which were granted accelerated approval12. However, despite these displays of flexibility and success, we are arguably no closer to delivering approved therapies that measaurably improve survival or QOL for patients with recurrent osteosarcoma. Clinical trials in rare diseases, particularly with paediatric populations, should not be treated with the same rules and regulations as other trials with large populations and diseases that manifest in adults.

Original title: “Novel regulatory science considerations in osteosarcoma: the imperative for regulatory flexibility to meet critical unmet patient and clinical needs - Drug Discovery World (DDW)”

The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces the issuance of an Order under Section 362 and 365 of the Public Health Service Act that suspends the introduction of certain persons from countries where an outbreak of a communicable disease exists for a period of 30 days. The Order was issued on May 18, 2026.

Original title: “Notice of Order Under Sections 362 and 365 of the Public Health Service Act Suspending Introduction of Certain Persons From Countries Where a Communicable Disease Exists”

Central to the proposal is a new ... combine clinical trial approval with a progressive route to market authorisation approval. This means that where there is limited evidence, patients could gain access to innovative treatments earlier, subject to approval by the National Institute for Health and Care Excellence (NICE) on NHS use. Compressing the regulatory pathway in this way is expected to reduce the cost of developing rare disease therapies and potentially ... Central to the proposal is a new Investigational Marketing Authorisation, which would combine clinical trial approval with a progressive route to market authorisation approval. This means that where there is limited evidence, patients could gain access to innovative treatments earlier, subject to approval by the National Institute for Health and Care Excellence (NICE) on NHS use. Compressing the regulatory pathway in this way is expected to reduce the cost of developing rare disease therapies and potentially make medications more affordable. Ultra-rare cancers can strike with no targeted treatment available. Myotonic Dystrophy slowly steals muscle function, affecting not just movement but breathing and heart function. What these conditions share is that the current system was not built for them. Developing therapies for rare diseases is genuinely hard. Patient numbers are small, scientific understanding is often limited, and the financial case for investment is weak. The regulatory rules that govern clinical trials and drug approvals were designed around common diseases – they assume large patient populations and the kind of definitive clinical trial data that is simply impossible to generate when a condition affects approximately one in 50,000 or fewer people. The MHRA launches public consultation on new framework that could lead to earlier licensing for therapies for up to 3.5 million people in the UK. By helping innovative therapies reach patients faster, this framework has the potential to transform lives, strengthen the UK’s position as a global leader in life sciences, and give renewed hope to families who have waited too long for progress. I encourage patients, clinicians, researchers and carers to take part in this consultation and help shape the future of rare disease treatment in the UK.

Original title: “Landmark new plans bring treatments for rare diseases a step closer - GOV.UK”

The new guidance is designed to utilise these strengths within a coherent enabling framework, positioning the UK as the destination of choice for rare disease therapy development and clinical trials, while safeguarding patients and maintaining confidence in regulatory decision-making. By helping innovative therapies reach patients faster, this framework has the potential to transform lives, strengthen the UK’s position as a global leader in life sciences, and give renewed hope to families who have waited too long for progress. I encourage patients, clinicians, researchers and carers to take part in this consultation and help shape the future of rare disease treatment in the UK. But even when there’s real promise in the science, treatments can take far too long to reach them because the regulatory pathways were not designed with rare diseases in mind. This consultation is a chance to design a better way forward: one that enables therapies to reach patients faster without compromising safety. We’d encourage companies, researchers, clinicians and patient groups to get involved so the final framework reflects their expertise and experience. Patients living with rare diseases often face significant barriers in accessing effective treatments. This consultation marks an important step towards a more flexible and responsive regulatory system that reflects the challenges and realities of rare disease development. For developers, the guidance provides a more streamlined and efficient process. A single authorisation removes the need for a discrete transition from clinical trial approval to marketing authorisation, supports more predictable and adaptable evidence requirements, and allows for rolling data submissions to accelerate decision-making. Proposed Rare Disease Therapies Framework introduces Investigational Marketing Authorisation and compressed development pathways – industry urged to respond

Original title: “MHRA consults on new regulatory framework to make UK a global leader in rare disease therapy development - GOV.UK”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 8908: To amend subsection (q) of section 505 of the Federal Food, Drug, and Cosmetic Act to clarify the process for denying certain petitions whose primary purpose is to delay the approval of an application submitted under subsection (b)(2) or (j) of such section 505, and for other purposes.”

While the manufacturer is on the list of authorized GLP-1 importers, FDA inspectors found the company relabeled APIs from another site in a potential attempt to “circumvent safeguards.”

Original title: “FDA sends warning letter after Chinese supplier breaks GLP-1 import restrictions”

FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products

Original title: “FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products ”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 4189: A bill to reduce the price of insulin and provide for patient protections with respect to the cost of insulin.”

Read twice and referred to the Committee on Commerce, Science, and Transportation.

Original title: “S 3188: A bill to establish a Biopharmaceutical Center of Excellence, and for other purposes.”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 1500: A bill to amend title XXVII of the Public Health Service Act to prohibit group health plans and health insurance issuers offering group or individual health insurance coverage from imposing cost-sharing requirements with respect to diagnostic and supplemental breast examinations.”

Read twice and referred to the Committee on Homeland Security and Governmental Affairs.

Original title: “S 823: A bill to create intergovernmental coordination between State, local, Tribal, and territorial jurisdictions, and the Federal Government to combat United States reliance on the People's Republic of China and other covered countries for critical minerals and rare earth metals, and for other purposes.”