Pharmaceutical industry news
Fresh coverage across pharma, biotech, medtech, research, approvals, and market-moving developments.
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Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: AIDS Drug Assistance Program-Transformation: Optimization and Best Practices in the Evolving Health Care Landscape, OMB No. 0906-XXXX-New
In compliance with the requirement for opportunity for public comment on proposed data collection pr...
Notice of Amended Order Requirement for Attestation by All Persons Arriving in the United States From Any Foreign Country Via Transportation by Aircraft and Controlled Free Pratique for Airlines and Other Aircraft Operators Confirming That Such Persons Have Not Been in the Democratic Republic of the
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Hu...
Essential Drug Delivery Performance Characteristics for Devices Intended To Deliver Drugs and Biological Products; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft g...
Medicare Program; CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Acute Kidney Injury (AKI) Dialysis Payment, and ESRD Quality Incentive Program
This final rule updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System fo...
Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep Apnea
The Food and Drug Administration (FDA) is classifying the over-the-counter device to assess risk of...
Medical Devices; Anesthesiology Devices; Classification of the Spinal Imaging System for Neuraxial Procedures
The Food and Drug Administration (FDA) is classifying the spinal imaging system for neuraxial proced...
Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease
The Food and Drug Administration (FDA) is classifying the radiology software for referral of finding...
Medical Devices; General and Plastic Surgery Devices; Classification of the Software-Aided Adjunctive Diagnostic Device for Use by Physicians on Lesions Suspicious for Skin Cancer
The Food and Drug Administration (FDA) is classifying the software-aided adjunctive diagnostic devic...
Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Third Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661
The Food and Drug Administration (FDA or Agency) is extending the effective date of the notice publi...






