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How HRSA defines eligibility and registration for 340B child sites and off-site outpatient facilities in 2026, and what makes them auditable.
Practical 340B compliance guide for setting up split-billing software to align virtual inventory, purchasing, and dispensing data.
How HRSA defines 340B overcharges, validates manufacturer data, and compels refunds when ceiling prices are exceeded in 2026.
HRSA’s 340B contract pharmacy registration hinges on verified site eligibility, written agreements, and precise OPAIS records.
HRSA’s duplicate discount prohibition defines Medicaid overlap rules and recordkeeping expectations that every 340B covered entity must understand.
HRSA’s 2026 audits are tightening around Medicaid Exclusion File accuracy and duplicate discount controls for FQHCs and community health centers.
FQHCs are under tighter HRSA audit scrutiny in 2026: eligibility records, Medicaid duplicate discount flags, and contract pharmacy inventory data are key.
HRSA’s 2026 enforcement push exposes how health system mergers disrupt 340B eligibility, contract pharmacy integrity, and re-registration.
How HRSA’s 2026 audits are reshaping 340B compliance expectations for oncology infusion centers, from infusion notes to contract pharmacy claim matching.
HRSA’s 2026 scrutiny of 340B diversion controls now targets specialty pharmacy shipments, patient definitions, and contract pharmacy oversight.
HRSA’s 2026 audits now target 340B contract pharmacy data integrity across multi-site systems, forcing covered entities to confront split-billing mismatches and origination errors.
HRSA’s 2026 oversight of 340B program integrity in mobile health units now targets gaps in eligibility, dispensing records, and contract pharmacy tie-ins.
Dialysis centers face new HRSA 2026 audit priorities on 340B patient eligibility, inventory control, and contract pharmacy oversight.
Behavioral health hospitals face new HRSA 2026 audit priorities around patient definition, documentation, and contract pharmacy oversight.
HRSA’s 2026 audits are zeroing in on eligibility, prescription origination, and contract pharmacy matching at women’s health clinics.
How rural health clinics can align with HRSA’s 2026 audit focus on provider eligibility, dispensing records, and contract pharmacy oversight.
HRSA’s 2026 contract pharmacy oversight focuses on restocking delays tied to manufacturer shipping pauses and ESP data mismatches.
HRSA’s 2026 340B audits are targeting clinic-dispense programs. Here’s how pharmacy-owned clinics can prove prescription origin and link inventory cleanly.
HRSA’s 2026 340B audits are hitting outpatient mental health clinics harder on eligibility proof and contract pharmacy claim checks.
HRSA’s 2026 enforcement focus on telehealth-dispensed 340B prescriptions is exposing diversion risks for FQHC and hospital covered entities.
HRSA audits in 2026 are targeting outpatient surgery centers in 340B. Here’s how to track inventory, handle contract pharmacies, and stay compliant.
HRSA audits in 2026 are zeroing in on hospital 340B discharge prescription conversions from inpatient stock, raising new compliance risks.
HRSA’s 2026 oversight of 340B ESP data and manufacturer access restores is testing covered entities’ compliance systems and data accuracy.
HRSA's 2026 audits now target specialty drug replenishment and contract pharmacy oversight, demanding precision in split-billing accuracy and data validation.
Live headlines from leading pharma and regulatory news sources. Links open original articles.
Part of a wave of young biotechs employing AI to accelerate research, the company claimed in regulatory filings that its approach has the potential to "disrupt legacy drug discovery paradigms."
This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in t
FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.
See updates from CDER on fast-moving issues and learn about CDER's work to enhance public health
In a first, a subcutaneously administered RNA interference medicine crossed into the brain and plummeted levels of a protein implicated in the disease.
Rare Disease Regulatory Framework
The U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to reimagine the development of d
On October 28, 2026, the U.S. Food and Drug Administration, in partnership with the Reagan-Udall Foundation for the FDA, will convene a hybrid public meeting to seek input related to the FDA’s Rare Di
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 13, 2026 – Par Health is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) to the hospital/user level. This recall is being conducted d
Wall Street analysts believe Verastem's drug to now be "competitive" in what's quickly become one of the most active and crowded areas of oncology research.
Prosecutors say the company filled unnecessary prescriptions that fueled the opioid epidemic. A spokesperson for CVS said the company admitted to no wrongdoing and "strongly disagreed" with the case's
A 6% sell-off in J&J shares was viewed by one analyst as emblematic of broader market volatility. Elsewhere, Gilead is collaborating with Vir and a biotech's bid for a product expansion fell short
Discover why flow paths, tubing and connectors may limit your bioprocess performance
One lawyer involved noted how it's yet another example of Paragon and key investor Fairmount - which have helped transform the reputation for reverse mergers - quickly executing on a complicated deal.
An early data check showed the shot didn't delay tumor progression in a form of head and neck cancer, though BioNTech is holding out hope it might eventually extend survival.
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