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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

Real-World Experience with 177 Lu-PSMA-617 Radioligand Therapy After Food and Drug Administration Approval.

  • Authors : Moradi Tuchayi A; Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, California.; Yadav S

Subjects: Lutetium*/Lutetium*/Lutetium*/therapeutic use ; Heterocyclic Compounds, 1-Ring*/Heterocyclic Compounds, 1-Ring*/Heterocyclic Compounds, 1-Ring*/therapeutic use ; Dipeptides*/Dipeptides*/Dipeptides*/therapeutic use

  • Source: Journal of nuclear medicine : official publication, Society of Nuclear Medicine [J Nucl Med] 2024 May 01; Vol. 65 (5), pp. 735-739. Date of Electronic Publication: 2024 May 01.Publisher: Society of Nuclear Medicine Country of Publication: United States NLM ID: 0217410

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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

Experience and impact of inappropriate patient sexual behaviors within a large VA healthcare system.

  • Authors : Gebhardt HM; VA Puget Sound Healthcare System, Seattle Division, Seattle, USA.; Norr AM

Subjects: United States Department of Veterans Affairs* ; Sexual Behavior*; Humans

  • Source: Journal of hospital medicine [J Hosp Med] 2024 May; Vol. 19 (5), pp. 394-398. Date of Electronic Publication: 2024 Mar 04.Publisher: Wiley Country of Publication: United States NLM ID: 101271025 Publication Model:

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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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  • 10-20 of  83,934,990 results for "%22United%20States%22"