Literature DB >> 22232155

The FDA and new safety warnings.

Thomas J Moore, Sonal Singh, Curt D Furberg.   

Abstract

Mesh：

Year:  2012        PMID： 22232155     DOI： 10.1001/archinternmed.2011.618

Source DB:  PubMed          Journal:  Arch Intern Med        ISSN： 0003-9926


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  13 in total

1.  Sources of information used by regulatory agencies on the generation of drug safety alerts.

Authors:  Carlos Alves; Ana Filipa Macedo; Francisco Batel Marques
Journal:  Eur J Clin Pharmacol       Date:  2013-07-27       Impact factor: 2.953

2.  A description of signals during the first 18 months of the EMA pharmacovigilance risk assessment committee.

Authors:  Alexandra C Pacurariu; Preciosa M Coloma; Anja van Haren; Georgy Genov; Miriam C J M Sturkenboom; Sabine M J M Straus
Journal:  Drug Saf       Date:  2014-12       Impact factor: 5.606

3.  Medicines Save, Medicines Kill.

Authors:  Joel Lexchin
Journal:  Drug Saf       Date:  2017-06       Impact factor: 5.606

4.  Drug-safety alerts issued by regulatory authorities: usefulness of meta-analysis in predicting risks earlier.

Authors:  Carlos Alves; Francisco Batel Marques; Ana Filipa Macedo
Journal:  Eur J Clin Pharmacol       Date:  2014-04-03       Impact factor: 2.953

5.  US Food and Drug Administration Safety Advisories and Reporting to the Adverse Event Reporting System (FAERS).

Authors:  Thomas J Moore; Richard L Morrow; Colin R Dormuth; Barbara Mintzes
Journal:  Pharmaceut Med       Date:  2020-04

6.  The Safety of Generic Prescription Drugs in the United States.

Authors:  Sonal Singh
Journal:  Drug Saf       Date:  2018-04       Impact factor: 5.606

7.  Defining and measuring meditation-related adverse effects in mindfulness-based programs.

Authors:  Willoughby B Britton; Jared R Lindahl; David J Cooper; Nicholas K Canby; Roman Palitsky
Journal:  Clin Psychol Sci       Date:  2021-11-01

8.  Use of case reports and the Adverse Event Reporting System in systematic reviews: overcoming barriers to assess the link between Crohn's disease medications and hepatosplenic T-cell lymphoma.

Authors:  Saranya A Selvaraj; Elizabeth Chairez; Lisa M Wilson; Mark Lazarev; Eric B Bass; Susan Hutfless
Journal:  Syst Rev       Date:  2013-07-05

9.  Respiratory depression in the post-anesthesia care unit: Mayo Clinic experience.

Authors:  Mariana L Laporta; Juraj Sprung; Toby N Weingarten
Journal:  Bosn J Basic Med Sci       Date:  2021-04-01       Impact factor: 3.363

Review 10.  Drug safety assessment in clinical trials: methodological challenges and opportunities.

Authors:  Sonal Singh; Yoon K Loke
Journal:  Trials       Date:  2012-08-20       Impact factor: 2.279
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