Informatics in Medical Product Regulation: The Right Drug at the Right Dose for the Right Patient

Author:

Almario Eileen Navarro,Kettermann Anna,Popat Vaishali

Publisher

Springer US

Reference115 articles.

1. Adler-Milstein J (2021) From digitization to digital transformation: policy priorities for closing the gap. JAMA 325(8):717–718. https://www.ncbi.nlm.nih.gov/pubmed/33620414

2. Maddali MV, Mehtani MV, Converse C et al (2019) Development and validation of HIV-ASSIST, an online, educational, clinical decision support tool to guide patient-centered ARV regimen selection. J Acquir Immune Defic Syndr 82(2):188–194. https://www.ncbi.nlm.nih.gov/pubmed/31513553

3. U.S. Food and Drug Administration (2018) Guidance for industry. Technical specifications document. Submitting select clinical trial data sets for drugs intended to treat human immunodficiency virus-1 infection. https://www.fda.gov/media/112667/download

4. Hamburg MA (2013) Paving the way for personalized medicine: FDA’s role in a new era of medical product development. https://www.fdanews.com/ext/resources/files/10/10-28-13-Personalized-Medicine.pdf

5. 21 U.S. Code § 352 (f) (1) (n.d.) Misbranded drugs and devices. https://uscode.house.gov/view.xhtml?req=(title:21%20section:352%20edition:prelim)

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