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New Alzheimer's drug clears FDA advisory vote despite unknowns.

• Authors : Couzin-Frankel J

Subjects: Alzheimer Disease*/Alzheimer Disease*/Alzheimer Disease*/drug therapy ; Antibodies, Monoclonal, Humanized*/Antibodies, Monoclonal, Humanized*/Antibodies, Monoclonal, Humanized*/administration & dosage ; Antibodies, Monoclonal, Humanized*/Antibodies, Monoclonal, Humanized*/Antibodies, Monoclonal, Humanized*/adverse effects

• Source: Science (New York, N.Y.) [Science] 2024 Jun 14; Vol. 384 (6701), pp. 1164-1165. Date of Electronic Publication: 2024 Jun 13.Publisher: American Association for the Advancement of Science Country of Publication: United States NLM ID:

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'Damning' FDA inspection report undermines Alzheimer's drug.

• Authors : Piller C

Subjects: Alzheimer Disease*/Alzheimer Disease*/Alzheimer Disease*/drug therapy ; Scientific Misconduct* ; Spiro Compounds*/Spiro Compounds*/Spiro Compounds*/therapeutic use

• Source: Science (New York, N.Y.) [Science] 2024 Mar 15; Vol. 383 (6688), pp. 1165-1166. Date of Electronic Publication: 2024 Mar 14.Publisher: American Association for the Advancement of Science Country of Publication: United States NLM ID:

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United States Food and Drug Administration seeks global regulatory regime.

• Authors : Walkinshaw E

Subjects: Internationality* ; Organizational Objectives* ; United States Food and Drug Administration*

• Source: CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne [CMAJ] 2011 Sep 06; Vol. 183 (12), pp. E777-8. Date of Electronic Publication: 2011 Aug Publisher: Canadian Medical Association Country of Publication: Canada NLM ID: 9711805 Publication Model: Print-Electronic Cited Medium: Internet

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Medical letter on the CDC & FDA. [electronic resource].

Subjects: Epidemiology -- United States -- Periodicals; Public health -- United States -- Periodicals; Communicable diseases -- United States -- PeriodicalsUnited StatesCenters for Disease Control and Prevention (U.S.); United States. Food and Drug Administration

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Utah flouts FDA with new placental stem cell law.

• Authors : Wadman M

Subjects: Placenta*/Placenta*/Placenta*/cytology ; Stem Cell Transplantation*/Stem Cell Transplantation*/Stem Cell Transplantation*/legislation & jurisprudence ; Stem Cells*/Stem Cells*/Stem Cells*/cytology

• Source: Science (New York, N.Y.) [Science] 2024 Apr 05; Vol. 384 (6691), pp. 14-15. Date of Electronic Publication: 2024 Apr 04.Publisher: American Association for the Advancement of Science Country of Publication: United States NLM ID:

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FDA enforcement actions plummet under Trump.

• Authors : Piller C

Subjects: United States Food and Drug Administration*; Health Policy/Health Policy/Health Policy/*trends; United States

• Source: Science (New York, N.Y.) [Science] 2019 Jul 05; Vol. 365 (6448), pp. 12-13.Publisher: American Association for the Advancement of Science Country of Publication: United States NLM ID:

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Summaries of safety labeling changes approved by FDA-Boxed warnings highlights, April-June 2018.

• Authors : Office of Health and Constituent Affairs, U.S. Food and Drug Administration

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

• Source: American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists [Am J Health Syst Pharm] 2018 Sep 01; Vol. 75 (17), pp. Publisher: Oxford University Press Country of Publication: England NLM ID: 9503023 Publication Model: Print Cited Medium: Internet ISSN:

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Summaries of safety labeling changes approved by FDA-Boxed warnings highlights October-December 2015.

• Authors : Office of Health & Constituent Affairs U.S. Food and Drug Administration

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

• Source: American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists [Am J Health Syst Pharm] 2016 Mar 01; Vol. 73 (5), pp. 267.Publisher: Oxford University Press Country of Publication: England NLM ID: 9503023 Publication Model: Print Cited Medium: Internet ISSN:

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Gene therapy milestone looms, but field seeks better options.

• Authors : Kaiser J

Subjects: Genetic Therapy*/Genetic Therapy*/Genetic Therapy*/adverse effects ; Genetic Therapy*/Genetic Therapy*/Genetic Therapy*/methods ; Genetic Therapy*/Genetic Therapy*/Genetic Therapy*/mortality

• Source: Science (New York, N.Y.) [Science] 2023 May 26; Vol. 380 (6647), pp. 778-779. Date of Electronic Publication: 2023 May 25.Publisher: American Association for the Advancement of Science Country of Publication: United States NLM ID:

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Report on trial death stokes Alzheimer's drug fears.

• Authors : Piller C

Subjects: Alzheimer Disease*/Alzheimer Disease*/Alzheimer Disease*/drug therapy ; Alzheimer Disease*/Alzheimer Disease*/Alzheimer Disease*/mortality ; Amyloid beta-Peptides*/Amyloid beta-Peptides*/Amyloid beta-Peptides*/immunology

• Source: Science (New York, N.Y.) [Science] 2023 Apr 14; Vol. 380 (6641), pp. 122-123. Date of Electronic Publication: 2023 Apr 13.Publisher: American Association for the Advancement of Science Country of Publication: United States NLM ID:

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