Global regulatory updates
Follow FDA, EMA, PMDA, MHRA, and other agencies across approvals, warnings, inspections, guidance, and drug policy signals.
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Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program
This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs)...
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) provides notice of the laboratories and Instrument...
Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guid...
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft g...
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; National Health Service Corps Scholar/Students to Service Travel Worksheet, OMB No. 0906-0087-Revision
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Req...
Proposed Collection; 60-Day Comment Request, Data Use Certification for the NIH Brain Development Cohorts (NBDC) Data Hub, (National Institute on Drug Abuse)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for...
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2027
This final rule finalizes changes and updates to the policies and payment rates used under the Skill...






