Pharmaceutical industry news

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

Agency Information Collection Activities: Submission for Office of Management and Budget Review (OMB); Comment Request

Proposed Information Collection Activity; TANF Contingency Fund Application

The Office of Family Assistance, Administration for Children and Families (ACF), U.S. Department of...

Proposed Data Collection Submitted for Public Comment and Recommendations

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to re...

Determination That Prednisolone Tablet, 5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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...

Agency Forms Undergoing Paperwork Reduction Act Review

Determination That RECTIV (Nitroglycerin) Ointment, 0.4%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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...

Agency Information Collection Activities: Submission for OMB Review; Comment Request

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to co...

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; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System

The Food and Drug Administration (FDA) is classifying the infant supine sleep system into class II (...

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; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test

The Food and Drug Administration (FDA) is classifying the SARS-CoV-2 serology test into class II (sp...

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...

Center for Scientific Review; Notice of Closed Meetings

NIH award: ChatBCT: Interdisciplinary Personalized Digital Health Analytics Training for Behavior Change

Recipient: ARIZONA STATE UNIVERSITY-TEMPE CAMPUS. Award amount: 2160.

NIH award: Determining the performance and accuracy of SILVAMP TB LAM and cost-effectiveness of diagnostic testing for TB meningitis

Recipient: UNIVERSITY OF MINNESOTA. Award amount: 148182.

NIH award: Genomic and Genomic Variation in Prostate Cancer

Recipient: DANA-FARBER CANCER INST. Award amount: 19607.

NIH award: Host-Pathogen Interaction in Leptospirosis

Recipient: UNIVERSITY OF CALIFORNIA LOS ANGELES. Award amount: 399987.

NIH award: Training and Research on Severe Malarial Anemia

Recipient: UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR. Award amount: 212534.

NIH award: Shape-based personalized AT(N) imaging markers of Alzheimer's disease

Recipient: UNIVERSITY OF SOUTHERN CALIFORNIA. Award amount: 746832.

NIH award: Plant-derived nanoparticles as a sepsis therapy

Recipient: UNIVERSITY OF MARYLAND BALTIMORE. Award amount: 233250.

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.

NIH award: Carbonic Anhydrase as a Cardioprotective Target in Anthracycline-induced Cardiotoxicity

Recipient: MEDICAL COLLEGE OF WISCONSIN. Award amount: 541272.

NIH award: Biological basis of cardiac thick filament regulation

Recipient: OHIO STATE UNIVERSITY. Award amount: 686983.

NIH award: Impact of systemic and cerebral acidosis on ischemic stroke and spreading depolarization

Recipient: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO. Award amount: 238410.

NIH award: Integrated Musculoskeletal Training Program

Recipient: COLUMBIA UNIV NEW YORK MORNINGSIDE. Award amount: 165832.

NIH award: E-cadherin deficient epithelium drives airway fibrosis in idiopathic subglottic stenosis

Recipient: JOHNS HOPKINS UNIVERSITY. Award amount: 735787.

NIH award: Tumor-targeted delivery of tetanus toxoid by Listeria reduces glioblastomas in mice

Recipient: ALBERT EINSTEIN COLLEGE OF MEDICINE. Award amount: 431970.

NIH award: Cardiovascular Structure and Function in the Mucopolysaccharidoses

Recipient: CHILDREN'S HOSPITAL OF ORANGE COUNTY. Award amount: 790852.

NIH award: The REASON Score: An Epigenetic And Clinicopathologic Score to Predict Risk of Poor Survival in Early Stage Oral Squamous Cell Carcinoma Patients

Recipient: LOMA LINDA UNIVERSITY. Award amount: 714757.

NIH award: Michigan Research Infrastructure for Population Sciences

Recipient: UNIVERSITY OF MICHIGAN AT ANN ARBOR. Award amount: 596918.

NIH award: C9orf72-mediated features transcriptomic signatures and translational studies for frontotemporal dementia and related disorders

Recipient: MAYO CLINIC JACKSONVILLE. Award amount: 528338.

NIH award: Core 1: Systems Pathology Core

Recipient: CEDARS-SINAI MEDICAL CENTER. Award amount: 256275.

NIH award: The Role of the Y Chromosome in Bladder Tumor Development, Growth And Progression

Recipient: CEDARS-SINAI MEDICAL CENTER. Award amount: 415819.

NIH award: Sex, Chromosomes, and Immunity in Bladder Cancer

Recipient: CEDARS-SINAI MEDICAL CENTER. Award amount: 2092602.

NIH award: Neuropeptide Y Receptor Signaling in Gut GVHD: Targeting Y1/Y2 Pathways for Immune Modulation

Recipient: COLUMBIA UNIVERSITY HEALTH SCIENCES. Award amount: 164500.

NIH award: Modeling bone metastasis and tumor dormancy in prostate cancer

Recipient: COLUMBIA UNIVERSITY HEALTH SCIENCES. Award amount: 820855.

NIH award: Core G: Biofluid Biomarker Core

Recipient: JOHNS HOPKINS UNIVERSITY. Award amount: 250711.

NIH award: Core C: Data Management and Statistics Core

Recipient: JOHNS HOPKINS UNIVERSITY. Award amount: 363463.

NIH award: Computational Model-Driven Design of Organ Scale Vasculature for Biomanufactured Tissues

Recipient: STANFORD UNIVERSITY. Award amount: 767249.

NIH award: Connectomic mapping of microcircuits underlying infant directed behavior

Recipient: HARVARD UNIVERSITY. Award amount: 670194.

NIH award: Biostatistics and Bioinformatics Facility

Recipient: RESEARCH INST OF FOX CHASE CAN CTR. Award amount: 186464.

NIH award: Protocol Review and Monitoring System

Recipient: RESEARCH INST OF FOX CHASE CAN CTR. Award amount: 204156.

NIH award: Clinical Protocol and Data Management

Recipient: RESEARCH INST OF FOX CHASE CAN CTR. Award amount: 446149.

NIH award: Cancer Prevention and Control Program

Recipient: RESEARCH INST OF FOX CHASE CAN CTR. Award amount: 67628.

NIH award: Cancer Center Administration

Recipient: RESEARCH INST OF FOX CHASE CAN CTR. Award amount: 33819.

NIH award: Multiomics and Antiretroviral Drug Exposure for assessing Metabolic Effects (MADE-FOR-ME)

Recipient: UNIVERSITY OF PITTSBURGH AT PITTSBURGH. Award amount: 514434.

NIH award: Lymphatic drainage dysfunction in chronic hypertension

Recipient: YALE UNIVERSITY. Award amount: 723383.

NIH award: Personalized Stroke Risk Stratification in Atrial Fibrillation: Integrating Probabilistic Graphical Models and High-dimensional EHR Data for Interpretable Prognosis

Recipient: DENVER HEALTH AND HOSPITAL AUTHORITY. Award amount: 536484.

NIH award: Identifying Organ-Specific Blood Biomarkers of Aging and Assessing their Effects on Cardiovascular Health

Recipient: BUCK INSTITUTE FOR RESEARCH ON AGING. Award amount: 776000.

NIH award: Integrative approach to discover genes that disentangle obesity from cardiometabolic risk in a large multi-ancestry study

Recipient: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI. Award amount: 856812.