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; Comment Request Proposed Project: Request To Publish the 30-Day Notices in the Federal Register To Solicit Public Comment on Information Collection for the Continued Approval and Updates for the Protection and Advocacy for Individuals Wi
Determination That Prednisolone Tablet, 5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that prednisolone tablet, 5 milligra...
Determination That RECTIV (Nitroglycerin) Ointment, 0.4%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that RECTIV (nitroglycerin) oin...
Unaccompanied Children Program Foundational Rule; Sponsor Assessment Update To Include Proof of Identity, Background Check, Placement, and Income Verification Standards
This notice of proposed rulemaking (NPRM, or proposed rule) would establish certain additional requi...
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice...
Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661
The Food and Drug Administration (FDA, Agency, or we) is extending the effective date of the notice...
Medicare Program; CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Acute Kidney Injury Dialysis (AKI) Payment, and ESRD Quality Incentive Program
This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment Sy...
Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizati...
Medical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome
The Food and Drug Administration (FDA) is classifying the external lower extremity nerve stimulator...
Medical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System
The Food and Drug Administration (FDA) is classifying the breast implant suction retrieval system in...
Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms
The Food and Drug Administration (FDA) is classifying the computerized behavioral therapy device for...
Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia
The Food and Drug Administration (FDA) is classifying the prognostic test for development or progres...
Medical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant
The Food and Drug Administration (FDA) is classifying the foam or gel chemical sterilant/high level...
Agency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Products
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on...
Solicitation for Public Comments on the Development of an Independent Accreditation System for Certified Community Behavioral Health Clinic Expansion (CCBHC-E) Grant Recipients
SAMHSA is seeking public comment to inform the development, implementation, and oversight of an inde...
NIH award: The Development and Evaluation of Visual Communication Tools to Convey Parental and Intergenerational Cardiovascular Disease Risk and Evoke Lifestyle Behavior Change
Recipient: RESEARCH INST NATIONWIDE CHILDREN'S HOSP. Award amount: 157920.