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Editorial & Opinion

A Perspective on Evaluating Life Stage Differences in Drug Dosages for Drug Labeling and Instructions.

  • Authors : Gu T; Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center, Memphis, Tennesse, 38103, USA.; Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100050, PR China.

Subjects: Drug Labeling*/Drug Labeling*/Drug Labeling*/standards; Humans ; Pharmaceutical Preparations/Pharmaceutical Preparations/Pharmaceutical Preparations/administration & dosage

  • Source: The AAPS journal [AAPS J] 2024 Aug 20; Vol. 26 (5), pp. 95. Date of Electronic Publication: 2024 Aug 20.Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited

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Academic Journal

Investigating Variations in Medicine Approvals for Attention-Deficit/Hyperactivity Disorder: A Cross-Country Document Analysis Comparing Drug Labeling.

  • Authors : Tanana L; School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.; Latif A

Subjects: Attention Deficit Disorder with Hyperactivity*/Attention Deficit Disorder with Hyperactivity*/Attention Deficit Disorder with Hyperactivity*/drug therapy ; Drug Labeling*/Drug Labeling*/Drug Labeling*/standards ; Central Nervous System Stimulants*/Central Nervous System Stimulants*/Central Nervous System Stimulants*/therapeutic use

  • Source: Journal of attention disorders [J Atten Disord] 2024 Sep; Vol. 28 (11), pp. 1437-1453. Date of Electronic Publication: 2024 Feb 07.Publisher: SAGE Publications Country of Publication: United States NLM ID: 9615686 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

Text summarization with ChatGPT for drug labeling documents.

  • Authors : Ying L; FDA National Center for Toxicological Research, Jefferson, AR 72079, USA.; Liu Z

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

  • Source: Drug discovery today [Drug Discov Today] 2024 Jun; Vol. 29 (6), pp. 104018. Date of Electronic Publication: 2024 May Publisher: Elsevier Science Ltd. Country of Publication: England NLM ID: 9604391 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling.

  • Authors : Neyarapally GA; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA. .; Wu L

Subjects: United States Food and Drug Administration* ; Drug Labeling*/Drug Labeling*/Drug Labeling*/standards ; Drug-Related Side Effects and Adverse Reactions*

  • Source: Drug safety [Drug Saf] 2024 Dec; Vol. 47 (12), pp. 1265-1274. Date of Electronic Publication: 2024 Jul 31.Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 9002928 Publication Model: Print-Electronic Cited Medium: Internet

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Academic Journal

Regulatory Impact of Selected U.S. FDA Postmarketing Safety Registries Conducted for Drugs Used to Treat Inflammatory or Autoimmune Conditions.

  • Authors : Guiriansoro Z; Division of Dermatology and Dentistry, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.; Oussova T

Subjects: Registries* ; Product Surveillance, Postmarketing*/Product Surveillance, Postmarketing*/Product Surveillance, Postmarketing*/methods ; United States Food and Drug Administration*/United States Food and Drug Administration*/United States Food and Drug Administration*/legislation & jurisprudence

  • Source: Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2024 Dec; Vol. 33 (12), pp. e70034.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

FDA Approval Summary: Capecitabine Labeling Update under Project Renewal.

  • Authors : Agrawal S; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence (OCE), U.S. Food and Drug Administration, Silver Spring, Maryland.

Subjects: Capecitabine*/Capecitabine*/Capecitabine*/adverse effects ; Capecitabine*/Capecitabine*/Capecitabine*/therapeutic use ; United States Food and Drug Administration*

  • Source: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2024 Dec 16; Vol. 30 (24), pp. 5508-5514.Publisher: American Association for Cancer Research Country of Publication: United States NLM ID: 9502500 Publication Model: Print Cited Medium:

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Academic Journal

Over-the-counter dermatology supplements- a practical guide to authenticity labels and reputable sources.

  • Authors : Mokhtari M; The Henry W. Lim, MD, Division of Photobiology and Photomedicine, Department of Dermatology, Henry Ford Health, 3031 W. Grand Blvd, Suite 700, Detroit, MI, 48202, USA.; Oakland University William Beaumont School of Medicine, Auburn Hills, MI, USA.

Subjects: Dietary Supplements*/Dietary Supplements*/Dietary Supplements*/adverse effects ; Dietary Supplements*/Dietary Supplements*/Dietary Supplements*/standards ; Drug Labeling*/Drug Labeling*/Drug Labeling*/standards

  • Source: Archives of dermatological research [Arch Dermatol Res] 2024 Dec 05; Vol. 317 (1), pp. 73. Date of Electronic Publication: 2024 Dec 05.Publisher: Springer Verlag Country of Publication: Germany NLM ID: 8000462 Publication Model: Electronic Cited Medium: Internet ISSN: 1432-069X

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Editorial & Opinion

Boxed warnings for dermatologic JAK inhibitors: are they standardized worldwide?

Subjects: Janus Kinase Inhibitors*/Janus Kinase Inhibitors*/Janus Kinase Inhibitors*/adverse effects ; Drug Labeling*/Drug Labeling*/Drug Labeling*/standards; Humans

  • Source: The Journal of dermatological treatment [J Dermatolog Treat] 2024 Dec; Vol. 35 (1), pp. 2403710. Date of Electronic Publication: 2024 Sep 18.Publisher: Informa Healthcare Country of Publication: England NLM ID: 8918133 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Academic Journal

Real-World Performance Benchmarks in the Reading Ability of Prescription Drug Labels by Community-Dwelling Older Adults.

  • Authors : Hakim R; Department of Ophthalmology, Loyola University Chicago, Stritch School of Medicine, Maywood, IL, USA.; Li M

Subjects: Drug Labeling*/Drug Labeling*/Drug Labeling*/standards ; Independent Living* ; Reading*

  • Source: Journal of pharmacy practice [J Pharm Pract] 2024 Dec; Vol. 37 (6), pp. 1275-1282. Date of Electronic Publication: 2024 Apr 22.Publisher: Sage Publications Country of Publication: United States NLM ID: 8900945 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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  • 1-10 of  41,729 results for ""DRUG labeling""