Literature DB >> 31615266

Generic Drugs Not as Safe as FDA Wants You to Believe.

C Michael White1.   

Abstract

Food and Drug Administration (FDA) rules for the production of prescription drugs are very rigorous and, if followed, guarantees a safe drug supply. For many years, foreign manufacturers have produced substandard generic products and active pharmaceutical ingredients and shipped them into the United States. If the FDA had inspected them with the same rigor as they do domestic manufacturers, they would have found many of these egregious deviations from ethical manufacturing much earlier. Although the FDA is finally stepping up the number of inspections, their current processes still rely on preannounced inspections with long time horizons, so quality issues can be temporarily corrected and documents altered or destroyed.

Keywords:  FDA; drug contamination; drug safety; generic drugs

Year:  2019        PMID: 31615266     DOI: 10.1177/1060028019881692

Source DB:  PubMed          Journal:  Ann Pharmacother        ISSN: 1060-0280            Impact factor:   3.154


  2 in total

1.  Comparative efficacy of generic nifedipine versus brand-name amlodipine for hypertension management in Taiwan.

Authors:  Hao-Wei Lee; Chin-Chou Huang; Hsin-Bang Leu; Yenn-Jiang Lin
Journal:  J Clin Hypertens (Greenwich)       Date:  2022-06-08       Impact factor: 2.885

2.  Comparison of Discounted and Undiscounted Cash Prices for Cardiovascular Medications by Type of US Community Pharmacy.

Authors:  Minji Hong; Natalia Shcherbakova
Journal:  J Gen Intern Med       Date:  2020-09-03       Impact factor: 5.128

  2 in total

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