Original title: “Statement of Delegation of Authority”

The FDA today announced a new initiative to allow its reviewers to access information from clinical trials in real time, with two major industry players already taking part in a pilot program. | The FDA today announced a new initiative to allow its reviewers to access information from clinical ... The FDA today announced a new initiative to allow its reviewers to access information from clinical trials in real time, with two major industry players already taking part in a pilot program. | The FDA today announced a new initiative to allow its reviewers to access information from clinical trials in real time, with two major industry players already taking part in a pilot program. The FDA is testing allowing its reviewers to access information from clinical trials in real-time, with AstraZeneca and Amgen already on board. “This program is an important first step towards strengthening clinical trial data collection,” Amy McKee, oncology senior vice president at AstraZeneca, said today at an FDA press conference. “The ultimate goal is to move data as quickly as possible across this ecosystem to accelerate our ability to bring new therapies to patients to make a meaningful difference in their lives.” She added that studies have found that trial participants are overwhelmingly okay with their patient-level data being shared, though this again is not planned for real-time trials. The bigger concern for Morain comes down to the balancing act between fast drug development and the assurance that a new drug is thoroughly vetted. “Patients want earlier access to new therapies, but they have interest in those therapies being safe and effective,” Morain said.

Original title: “FDA unveils plan for real-time review of clinical trial data, with AstraZeneca and Amgen already on board”

The U.S. Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT).

Original title: “FDA Announces Major Steps to Implement Real-Time Clinical Trials ”

Legislation to speed up clinical trials has come into force across the UK, under what the government has described as “the largest package of reforms in over 20 years”. On 27 April 2026, the government said that the new combined approval process “takes an average of 41 days, less than ... Legislation to speed up clinical trials has come into force across the UK, under what the government has described as “the largest package of reforms in over 20 years”. On 27 April 2026, the government said that the new combined approval process “takes an average of 41 days, less than half of the time it took a […] The Pharmaceutical Journal from the Royal College of Pharmacy In a blog published on 27 April 2026, the MHRA‘s clinical trials team said that the aim had been “to cut the time it takes us to review applications from 35 to 14 days”, adding that during a pilot of the Route B pathway, the average time had actually been seven days — “well below the 14-day threshold and significantly shorter than a standard substantial amendment”. Lawrence Tallon, chief executive of the MHRA, commented: “These reforms will help to make the UK a more attractive, internationally competitive destination for both commercial and non-commercial clinical research. Most importantly, patients will benefit from earlier access to the latest, innovative medicines. “We have listened carefully to the needs of patients, clinicians, researchers and industry to ensure we are delivering the most efficient, streamlined approvals process without compromising safety.”

Original title: “Legislation to speed up clinical trials comes into force - The Pharmaceutical Journal”

The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study personnel doctored the results of the drug’s pivotal study in order to make it look effective.

Original title: “FDA alleges 'manipulated' data supported approval of Amgen’s autoimmune drug”

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

Original title: “S 1924: Improving Mental Health Access for Students Act”

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be "delisted" by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, such as when a PSO chooses to voluntar

Original title: “Patient Safety Organizations: Voluntary Relinquishment for Collaborative Healthcare Patient Safety Organization”

The Administration for Children and Families' (ACF) Office of Planning, Research, and Evaluation (OPRE) requests Office of Management and Budget (OMB) approval of a revision of a previously approved overarching generic clearance to collect data on programs serving youth transitioning out of foster care as part of the Chafee Strengthening Outcomes for Transition to Adulthood Project. The generic mechanism will allow ACF to conduct rapid-cycle evaluations that would not otherwise be feasible under

Original title: “Proposed Information Collection Activity; Chafee Strengthening Outcomes for Transition to Adulthood Project Overarching Generic (Extension)”

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is proposing to renew the collection of expenditure estimate forms for the tribal child support program through an optional financial reporting form, Tribal Budget and Narrative Justification Template (Office of Management and Budget #: 0970-0548; expiration date May 31, 2026). Minor changes are proposed. OCSE does not plan to renew either the Word version

Original title: “Submission for Office of Management and Budget Review; Tribal Budget and Narrative Justification Template”

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Focus on Advancing Support and Transition with the Fragile X Online Registry With Acce

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”

Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”

Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”

FDA inspectors warned UCSF radiopharmaceutical facility that losing environmental control could pose a serious hazard to patients.

Original title: “UCSF, Par Health hit with FDA warning letters for environmental monitoring issues”

After striking a Most Favored Nation deal with the White House in January, Johnson & Johnson will now offer Xarelto at 68% off on TrumpRx, dropping its price from $611.82 to $197 per 30-pill pack.

Original title: “J&J puts blockbuster blood thinner Xarelto on TrumpRx”

prescription drugs affected by an expanded rare disease carve out from medicare price negotiation

Original title: “Prescription Drugs Affected by an Expanded Rare Disease Carve-Out from Medicare Price Negotiation.”

High out-of-pocket expenses for medicines remain a major barrier to healthcare access, particularly in low- and middle-income countries (LMICs), and often lead to financial hardship. Out-of-pocket health spending refers to direct, non-reimbursable payments made by individuals at the point of ... High out-of-pocket expenses for medicines remain a major barrier to healthcare access, particularly in low- and middle-income countries (LMICs), and often lead to financial hardship. Out-of-pocket health spending refers to direct, non-reimbursable payments made by individuals at the point of care covering medicines, consultations, and hospital services that are not fully covered by insurance. Early detection, timely intervention, and coordinated management of chronic diseases not only improve patient outcomes but also generate significant savings for both households and the health system. The Philippine government has taken important steps to improve affordability. The Tax Reform for Acceleration and Inclusion (TRAIN) Law and the Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act have exempted selected medicines, including those for cancer, hypertension, diabetes, mental health conditions, high cholesterol, kidney disease, and tuberculosis, from the 12% value-added tax (VAT). For individuals living with non-communicable diseases (NCDs) such as cancer and diabetes, this burden is particularly acute. Managing chronic conditions often requires long-term and continuous treatment, making affordability a decisive factor in health outcomes.

Original title: “Turning medicine policy into real patient access - BusinessWorld Online”

The Family and Youth Services Bureau's (FYSB) Runaway and Homeless Youth Division has a legislative requirement to fund a National Communication System, which is currently operated by the National Runaway Safeline (NRS). The NRS provides information, referral services, crisis intervention, and prevention resources to vulnerable youth at risk of running away and/or becoming homeless and their families or legal guardians at no cost. When necessary, the NRS refers runaway and homeless youth to shel

Original title: “Proposed Information Collection Activity; National Communication System for Runaway and Homeless Youth, Currently Operated by the National Runaway Safeline Data Collection”

The Food and Drug Administration (FDA) is announcing the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Anesthetic and Analgesic Drug Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 1, 2028, expiration date.

Original title: “Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; Renewal”