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Editorial & Opinion

The Next Chapter of Renal Denervation After US Food and Drug Administration Approval.

  • Authors : Vongpatanasin W; Hypertension Section (W.V.), Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas.; Cardiology Division (W.V., T.A.)., Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas.

Subjects: United States Food and Drug Administration*; United States ; Humans

  • Source: Circulation [Circulation] 2024 Mar 05; Vol. 149 (10), pp. 760-763. Date of Electronic Publication: 2024 Mar 04.Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 0147763

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Academic Journal

Rising cases of drug-induced pulmonary fibrosis: Analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) database, 2000-2022.

  • Authors : McCall KL; Department of Pharmacy Practice, Binghamton University School of Pharmacy & Pharmaceutical Sciences, Johnson City, New York, USA.; Hennig KR

Subjects: Adverse Drug Reaction Reporting Systems*/Adverse Drug Reaction Reporting Systems*/Adverse Drug Reaction Reporting Systems*/statistics & numerical data ; United States Food and Drug Administration* ; Databases, Factual*/Databases, Factual*/Databases, Factual*/statistics & numerical data

  • Source: Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2024 May; Vol. 33 (5), pp. e5797.Publisher: Wiley Country of Publication: England NLM ID: 9208369 Publication Model: Print Cited Medium: Internet ISSN: 1099-1557 (Electronic)

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Academic Journal

Clarification of Information in "Navigating Next-Generation Sequencing Laboratory Developed Tests: A Critical Look at Proficiency Testing, US Food and Drug Administration Regulations, and Clinical Laboratory Performance Tests".

  • Authors : Lockwood CM; Department of Laboratory Medicine and Pathology, University of Washington Medicine, Seattle.

Subjects: United States Food and Drug Administration* ; High-Throughput Nucleotide Sequencing* ; Laboratory Proficiency Testing*

  • Source: Archives of pathology & laboratory medicine [Arch Pathol Lab Med] 2024 May 01; Vol. 148 (5), pp. 507.Publisher: College of American Pathologists Country of Publication: United States NLM ID: 7607091

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Academic Journal

FDA Issues Warning About 'Gas Station Heroin'.

Subjects: United States Food and Drug Administration*; United States ; Humans

  • Source: The American journal of nursing [Am J Nurs] 2024 May 01; Vol. 124 (5), pp. 13. Date of Electronic Publication: 2024 Apr 25.Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 0372646

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Academic Journal

Safety evaluation of 8 drug degradants present in over-the-counter cough and cold medications.

  • Authors : Mihalchik AL; ToxStrategies, Research Triangle Park, NC, USA. Electronic address: .; Choksi NY

Subjects: Nonprescription Drugs*/Nonprescription Drugs*/Nonprescription Drugs*/adverse effects ; Antitussive Agents*/Antitussive Agents*/Antitussive Agents*/adverse effects ; United States Food and Drug Administration*

  • Source: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 May; Vol. 149, pp. 105621. Date of Electronic Publication: 2024 Apr 10.Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Evaluation of in silico model predictions for mammalian acute oral toxicity and regulatory application in pesticide hazard and risk assessment.

  • Authors : Bishop PL; Animal Research Issues, The Humane Society of the United States, Washington, DC, USA. Electronic address: .; Mansouri K

Subjects: Pesticides*/Pesticides*/Pesticides*/toxicity ; Quantitative Structure-Activity Relationship* ; Computer Simulation*

  • Source: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 May; Vol. 149, pp. 105614. Date of Electronic Publication: 2024 Apr 02.Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

A framework enabling LLMs into regulatory environment for transparency and trustworthiness and its application to drug labeling document.

  • Authors : Wu L; Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US FDA, 3900 NCTR Rd, Jefferson AR, 72211, USA. Electronic address: .; Xu J

Subjects: Drug Labeling*/Drug Labeling*/Drug Labeling*/standards ; Drug Labeling*/Drug Labeling*/Drug Labeling*/legislation & jurisprudence ; United States Food and Drug Administration*/United States Food and Drug Administration*/United States Food and Drug Administration*/standards

  • Source: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 May; Vol. 149, pp. 105613. Date of Electronic Publication: 2024 Apr 02.Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Commentary: Value of information case study strongly supports use of the Threshold of Toxicological Concern (TTC).

Subjects: United States Environmental Protection Agency*; Animals ; Humans

  • Source: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 May; Vol. 149, pp. 105594. Date of Electronic Publication: 2024 Mar 28.Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Review of the standards of proof (of safety) for FDA regulated consumer products and how the generally recognized as safe criteria could be applied to cosmetics.

  • Authors : Burdock GA; Burdock Group Consultants, Orlando, FL, 32814, USA. Electronic address: .

Subjects: Cosmetics*/Cosmetics*/Cosmetics*/standards ; United States Food and Drug Administration*/United States Food and Drug Administration*/United States Food and Drug Administration*/standards ; Consumer Product Safety*/Consumer Product Safety*/Consumer Product Safety*/standards

  • Source: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 May; Vol. 149, pp. 105603. Date of Electronic Publication: 2024 Mar 15.Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Medical device report analyses from MAUDE: Device and patient outcomes, adverse events, and sex-based differential effects.

  • Authors : Liao TJ; Office of Research, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, 72079, USA.; Crosby L

Subjects: Product Surveillance, Postmarketing* ; Equipment and Supplies*/Equipment and Supplies*/Equipment and Supplies*/adverse effects ; United States Food and Drug Administration*

  • Source: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 May; Vol. 149, pp. 105591. Date of Electronic Publication: 2024 Mar 11.Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

FDA approvals in 2023: biomarker-positive subsets, equipoise and verification of benefit.

  • Authors : Norsworthy KJ; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. .; Lee-Alonzo RJ

Subjects: United States Food and Drug Administration* ; Drug Approval* ; Biomarkers, Tumor*/Biomarkers, Tumor*/Biomarkers, Tumor*/genetics

  • Source: Nature reviews. Clinical oncology [Nat Rev Clin Oncol] 2024 May; Vol. 21 (5), pp. 333-334.Publisher: Nature Pub. Group Country of Publication: England NLM ID: 101500077 Publication Model: Print Cited Medium: Internet ISSN: 1759-4782

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Academic Journal

Olfactory-Related Adverse Events: An Analysis of the Food and Drug Administration Adverse Events Reporting System.

  • Authors : Minutello KM; Department of Otolaryngology-Head and Neck Surgery, Mclaren Oakland Hospital, Pontiac, Michigan, USA.; Lofgren DH

Subjects: Adverse Drug Reaction Reporting Systems* ; Olfaction Disorders*/Olfaction Disorders*/Olfaction Disorders*/chemically induced ; Olfaction Disorders*/Olfaction Disorders*/Olfaction Disorders*/epidemiology

  • Source: Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery [Otolaryngol Head Neck Surg] 2024 May; Vol. 170 (5), pp. 1296-1306. Publisher: Wiley Country of Publication: England NLM ID: 8508176 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6817

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Academic Journal

Assessing Readability of US Food and Drug Administration-Required Labeling for Breast Implants.

  • Authors : Krivanek TJ; Division of Plastic Surgery, Department of Surgery, University of Minnesota Medical Center, Minneapolis, MN.; Powell LE

Subjects: United States Food and Drug Administration*/United States Food and Drug Administration*/United States Food and Drug Administration*/standards ; Breast Implants*/Breast Implants*/Breast Implants*/adverse effects ; Comprehension*

  • Source: Plastic and reconstructive surgery [Plast Reconstr Surg] 2024 May 01; Vol. 153 (5), pp. 1050e-1052e. Date of Electronic Publication: 2023 Sep 26.Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 1306050

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Academic Journal

Multiple myeloma, haematologic malignancy and immunosuppressant and immunomodulatory medications are associated with sebaceous carcinoma, a pharmacovigilance study of the FDA adverse event reporting system.

  • Authors : Jedlowski PM; Division of Dermatology, University of Arizona College of Medicine - Tucson, Tucson, Arizona, USA.; DuPont JP

Subjects: Multiple Myeloma*/Multiple Myeloma*/Multiple Myeloma*/drug therapy ; Adverse Drug Reaction Reporting Systems* ; Immunosuppressive Agents*/Immunosuppressive Agents*/Immunosuppressive Agents*/adverse effects

  • Source: Journal of the European Academy of Dermatology and Venereology : JEADV [J Eur Acad Dermatol Venereol] 2024 May; Vol. 38 (5), pp. 937-944. Date of Electronic Publication: 2023 Dec Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 9216037 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Phosphodiesterase type 5 inhibitors related hearing impairment: a real world study based on the FDA adverse event reporting system.

  • Authors : Zhang X; Department of Pharmacy, Suining Central Hospital, No.127, West Desheng Road, Chuanshan District, Suining, 629000, Sichuan, People's Republic of China.; Xia L

Subjects: United States Food and Drug Administration* ; Hearing Loss*/Hearing Loss*/Hearing Loss*/chemically induced ; Hearing Loss*/Hearing Loss*/Hearing Loss*/epidemiology

  • Source: Scientific reports [Sci Rep] 2024 Apr 28; Vol. 14 (1), pp. 9743. Date of Electronic Publication: 2024 Apr 28.Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN:

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Academic Journal

Clinician and staff experiences with frustrated patients during an electronic health record transition: a qualitative case study.

  • Authors : Ball SL; VA Northeast Ohio Healthcare System, 10701 East Blvd., Research Service 151, 44106, Cleveland, OH, USA. .; Kim B

Subjects: Electronic Health Records* ; Qualitative Research* ; United States Department of Veterans Affairs*

  • Source: BMC health services research [BMC Health Serv Res] 2024 Apr 26; Vol. 24 (1), pp. 535. Date of Electronic Publication: 2024 Apr 26.Publisher: BioMed Central Country of Publication: England NLM ID: 101088677 Publication Model: Electronic Cited Medium: Internet ISSN: 1472-6963

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Academic Journal

Culture change and lessons learned from ten years in the VA centers of excellence in primary care education.

  • Authors : Weppner WG; Division of General Internal Medicine, University of Washington School of Medicine, Seattle, WA, USA. .; School of Medicine, University of Washington, Boise VAMC, MSO-111, 500 W. Fort St, 83702

Subjects: Primary Health Care*/Primary Health Care*/Primary Health Care*/standards ; Organizational Culture* ; United States Department of Veterans Affairs*

  • Source: BMC medical education [BMC Med Educ] 2024 Apr 26; Vol. 24 (1), pp. 457. Date of Electronic Publication: 2024 Apr 26.Publisher: BioMed Central Country of Publication: England NLM ID: 101088679 Publication Model: Electronic Cited Medium: Internet ISSN: 1472-6920

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Academic Journal

A real-world pharmacovigilance study of amivantamab-related cardiovascular adverse events based on the FDA adverse event reporting system (FAERS) database.

  • Authors : Sun R; Department of Oncology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.; Ning Z

Subjects: Pharmacovigilance* ; Cardiovascular Diseases*/Cardiovascular Diseases*/Cardiovascular Diseases*/epidemiology ; Cardiovascular Diseases*/Cardiovascular Diseases*/Cardiovascular Diseases*/chemically induced

  • Source: Scientific reports [Sci Rep] 2024 Apr 25; Vol. 14 (1), pp. 9552. Date of Electronic Publication: 2024 Apr 25.Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN:

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Academic Journal

Perspectives on supporting Veterans' social needs during hospital to home health transitions: findings from the Transitions Nurse Program.

  • Authors : Daus M; Denver/Seattle Center of Innovation for Veteran-Centered and Value Driven Care, VHA Eastern Colorado Healthcare System, 1700 N Wheeling St, Aurora, CO, 80045, USA. .; Lee M

Subjects: Home Care Services*/Home Care Services*/Home Care Services*/organization & administration ; Veterans*/Veterans*/Veterans*/psychology ; Qualitative Research*

  • Source: BMC health services research [BMC Health Serv Res] 2024 Apr 25; Vol. 24 (1), pp. 520. Date of Electronic Publication: 2024 Apr 25.Publisher: BioMed Central Country of Publication: England NLM ID: 101088677 Publication Model: Electronic Cited Medium: Internet ISSN: 1472-6963

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Academic Journal

Development and validation of a pulmonary function test data extraction tool for the US department of veterans affairs electronic health record.

  • Authors : Rabin AS; Pulmonary Section, Veterans Affairs Ann Arbor Healthcare System, 2215 Fuller Road, 48105, Ann Arbor, MI, USA. .; Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, MI, USA. .

Subjects: Electronic Health Records*/Electronic Health Records*/Electronic Health Records*/statistics & numerical data ; United States Department of Veterans Affairs* ; Respiratory Function Tests*/Respiratory Function Tests*/Respiratory Function Tests*/methods

  • Source: BMC research notes [BMC Res Notes] 2024 Apr 23; Vol. 17 (1), pp. 115. Date of Electronic Publication: 2024 Apr 23.Publisher: Biomed Central Country of Publication: England NLM ID: 101462768 Publication Model: Electronic Cited Medium: Internet ISSN: 1756-0500

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Academic Journal

A Patchy Prohibition: Product and Flavor Substitution After the Food and Drug Administration's Prioritized Enforcement Policy on Flavored E-cigarettes.

  • Authors : Borowiecki M; Department of Public Health, NORC At The University of Chicago, Chicago, IL, USA.; Kim Y

Subjects: Electronic Nicotine Delivery Systems*/Electronic Nicotine Delivery Systems*/Electronic Nicotine Delivery Systems*/economics ; Electronic Nicotine Delivery Systems*/Electronic Nicotine Delivery Systems*/Electronic Nicotine Delivery Systems*/statistics & numerical data ; United States Food and Drug Administration*

  • Source: Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco [Nicotine Tob Res] 2024 Apr 22; Vol. 26 (5), pp. 527-535.Publisher: Oxford University Press Country of Publication: England NLM ID: 9815751 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

The FDA in the Crosshairs-Science, Politics, and Abortion.

Subjects: Abortion, Induced*/Abortion, Induced*/Abortion, Induced*/legislation & jurisprudence ; Abortion, Induced*/Abortion, Induced*/Abortion, Induced*/methods ; Politics*

  • Source: JAMA [JAMA] 2024 Apr 16; Vol. 331 (15), pp. 1269-1270.Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160

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Academic Journal

Celebrating a breakthrough: FDA endorses encorafenib plus binimetinib alongside two companion diagnostics for BRAV600E mutant metastatic non-small cell lung cancer.

  • Authors : Abbasi HQ; Department of Internal Medicine, Ayub Medical College, Abbottabad, Pakistan.; Oduoye MO

Subjects: Sulfonamides*/Sulfonamides*/Sulfonamides*/administration & dosage ; Carcinoma, Non-Small-Cell Lung*/Carcinoma, Non-Small-Cell Lung*/Carcinoma, Non-Small-Cell Lung*/drug therapy ; Carcinoma, Non-Small-Cell Lung*/Carcinoma, Non-Small-Cell Lung*/Carcinoma, Non-Small-Cell Lung*/genetics

  • Source: International journal of surgery (London, England) [Int J Surg] 2024 Apr 01; Vol. 110 (4), pp. 1894-1895. Date of Electronic Publication: 2024 Apr 01.Publisher: Wolters Kluwer Health, Inc Country of Publication: United States NLM ID: 101228232

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Academic Journal

An empirical analysis of overall survival in drug approvals by the US FDA (2006-2023).

  • Authors : Elbaz J; Hofstra University, Hempstead, New York, USA.; Haslam A

Subjects: Drug Approval*/Drug Approval*/Drug Approval*/statistics & numerical data ; United States Food and Drug Administration* ; Antineoplastic Agents*/Antineoplastic Agents*/Antineoplastic Agents*/therapeutic use

  • Source: Cancer medicine [Cancer Med] 2024 Apr; Vol. 13 (8), pp. e7190.Publisher: John Wiley & Sons Ltd Country of Publication: United States NLM ID: 101595310 Publication

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Academic Journal

Neurological Care within the Indian Health Service.

  • Authors : Parko K; Department of Neurology, University of California at San Francisco, San Francisco, California.; Stitzer M

Subjects: United States Indian Health Service* ; American Indian or Alaska Native* ; Neurology*

  • Source: Seminars in neurology [Semin Neurol] 2024 Apr; Vol. 44 (2), pp. 205-216. Date of Electronic Publication: 2024 Mar 18.Publisher: Thieme Stratton Country of Publication: United States NLM ID: 8111343 Publication Model:

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  • 1-25 of  83,921,290 results for "%22UNITED%20States%22"