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Editorial & Opinion

FDA Label for Over-the-Counter Naloxone.

  • Authors : Fisher DM; University of California, San Francisco, San Francisco, CA .; Shafer SL

Subjects: Drug Labeling* ; Naloxone*; Nonprescription Drugs

  • Source: The New England journal of medicine [N Engl J Med] 2020 Sep 10; Vol. 383 (11), pp. 1092-1093.Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone.

  • Authors : Cohen BR; From the Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.; Mahoney KM

Subjects: Comprehension* ; Drug Labeling*/Drug Labeling*/Drug Labeling*/legislation & jurisprudence; Analgesics, Opioid/Analgesics, Opioid/Analgesics, Opioid/*poisoning

  • Source: The New England journal of medicine [N Engl J Med] 2020 May 28; Vol. 382 (22), pp. 2129-2136.Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

Immunotherapy Combinations in Multiple Myeloma - Known Unknowns.

  • Authors : Gormley NJ; From the Food and Drug Administration, Silver Spring, MD.; Pazdur R

Subjects: Drug Labeling*; Antibodies, Monoclonal/Antibodies, Monoclonal/Antibodies, Monoclonal/*adverse effects ; Antibodies, Monoclonal, Humanized/Antibodies, Monoclonal, Humanized/Antibodies, Monoclonal, Humanized/*adverse effects

  • Source: The New England journal of medicine [N Engl J Med] 2018 Nov 08; Vol. 379 (19), pp. 1791-1795.Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

Inhaled Corticosteroids and LABAs - Removal of the FDA's Boxed Warning.

  • Authors : Seymour SM; From the Office of New Drugs (S.M.S., R.L., B.A.C.) and the Office of Translational Sciences ( C.X., E.A.-C.), Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.; Lim R

Subjects: Drug Combinations* ; Drug Labeling*; Adrenal Cortex Hormones/Adrenal Cortex Hormones/Adrenal Cortex Hormones/*administration & dosage

  • Source: The New England journal of medicine [N Engl J Med] 2018 Jun 28; Vol. 378 (26), pp. 2461-2463.Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

Anesthesia and Developing Brains - Implications of the FDA Warning.

  • Authors : Andropoulos DB; From the Department of Anesthesiology, Texas Children's Hospital and Baylor College of Medicine, Houston (D.B.A.); and the Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston (M.F.G.).

Subjects: Drug Labeling*; Anesthesia, General/Anesthesia, General/Anesthesia, General/*adverse effects ; Anesthetics, General/Anesthetics, General/Anesthetics, General/*adverse effects

  • Source: The New England journal of medicine [N Engl J Med] 2017 Mar 09; Vol. 376 (10), pp. 905-907. Date of Electronic Publication: 2017 Feb 08.Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

The Vernacular of Risk--Rethinking Direct-to-Consumer Advertising of Pharmaceuticals.

  • Authors : Greene JA; From the Division of General Internal Medicine and the Department of the History of Medicine, Johns Hopkins University School of Medicine, Baltimore (J.A.G.); and the Department of Anthropology, History and Social Medicine, University of California, San Francisco, School of Medicine, San Francisco (E.S.W.).

Subjects: Advertising/Advertising/Advertising/*legislation & jurisprudence ; Drug Labeling/Drug Labeling/Drug Labeling/*history ; Government Regulation/Government Regulation/Government Regulation/*history

  • Source: The New England journal of medicine [N Engl J Med] 2015 Sep 17; Vol. 373 (12), pp. 1087-9. Date of Electronic Publication: 2015 Aug 19.Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print-Electronic Cited Medium:

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Academic Journal

Testosterone and "Age-Related Hypogonadism"--FDA Concerns.

  • Authors : Nguyen CP; From the Food and Drug Administration, Silver Spring, MD.; Hirsch MS

Subjects: Drug Labeling*/Drug Labeling*/Drug Labeling*/legislation & jurisprudence ; Off-Label Use*; Cardiovascular Diseases/Cardiovascular Diseases/Cardiovascular Diseases/*chemically induced

  • Source: The New England journal of medicine [N Engl J Med] 2015 Aug 20; Vol. 373 (8), pp. 689-91.Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

Risk, responsibility, and generic drugs.

  • Authors : Kesselheim AS; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, USA.; Avorn J

Subjects: Drugs, Generic*/Drugs, Generic*/Drugs, Generic*/adverse effects ; Drugs, Generic*/Drugs, Generic*/Drugs, Generic*/history ; Liability, Legal*/Liability, Legal*/Liability, Legal*/history

  • Source: The New England journal of medicine [N Engl J Med] 2012 Nov 01; Vol. 367 (18), pp. 1679-81.Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print Cited Medium: Internet ISSN:

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Academic Journal

Responding to an FDA warning--geographic variation in the use of rosiglitazone.

  • Authors : Shah ND; Knowledge and Encounter Research Unit, Mayo Clinic, Rochester, MN, USA.; Montori VM

Subjects: Drug Labeling*/Drug Labeling*/Drug Labeling*/legislation & jurisprudence; Drug Prescriptions/Drug Prescriptions/Drug Prescriptions/*statistics & numerical data ; Hypoglycemic Agents/Hypoglycemic Agents/Hypoglycemic Agents/*therapeutic use

  • Source: The New England journal of medicine [N Engl J Med] 2010 Nov 25; Vol. 363 (22), pp. 2081-4. Date of Electronic Publication: 2010 Nov 17.Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print-Electronic Cited Medium:

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Editorial & Opinion

FDA drug information that never reaches clinicians.

Subjects: Drug Labeling* ; Information Dissemination* ; United States Food and Drug Administration*

  • Source: The New England journal of medicine [N Engl J Med] 2010 Feb 11; Vol. 362 (6), pp. 562-3; author reply 563.Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print Cited Medium: Internet ISSN:

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