Implementing a public health perspective in FDA drug regulation

PJ Zettler, MF Riley, AS Kesselheim - Food & Drug LJ, 2018 - HeinOnline
There is, without question, a public health crisis in the United States arising from both illicit
and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration …

Precision medicine: drowning in a regulatory soup?

D Nicol, T Bubela, D Chalmers… - Journal of Law and …, 2016 - academic.oup.com
6. Centre for Health, Law and Emerging Technologies, University of Oxford, Oxford,
Oxfordshire, UK 7. Faculty of Law, University of Cambridge, Cambridge, Cambridgeshire …

Compounded nonsterile preparations and FDA-approved commercially available liquid products for children: A North American update

RH Parrish, LD Ashworth, R Löbenberg, S Benavides… - Pharmaceutics, 2022 - mdpi.com
The purpose of this work was to evaluate the suitability of recent US Food and Drug
Administration (US-FDA)-approved and marketed oral liquid, powder, or granule products …

The Indirect Consequences of Expanded Off-Label Promotion

PJ Zettler - Ohio St. LJ, 2017 - HeinOnline
The US Food and Drug Administration (FDA) plays a vital public health role. It oversees
human and animal medical products, food, dietary supplements, cosmetics, products that …

The FDA's Power over Non-Therapeutic Uses of Drugs and Devices

PJ Zettler - Wash. & Lee L. Rev., 2021 - HeinOnline
Although we often-and rightly-think of the US Food and Drug Administration (FDA) as
regulating important therapies for patients, the agency also can regulate non-therapeutic …

Reforming regenerative medicine regulation

S Duranske - Ga. St. UL Rev., 2017 - HeinOnline
The gods were angry. Prometheus and his brother had endowed the creatures of the earth
with gifts to help them survive and prosper: speed, cunning, strength. But, in error …

Repurposing old drugs for new uses

K Brown - DePaul J. Art Tech. & Intell. Prop. L, 2017 - HeinOnline
REPURPOSING OLD DRUGS FOR NEW USES Page 1 REPURPOSING OLD DRUGS FOR
NEW USES I. INTRODUCTION Despite recent advancements in the drug discovery and …

A Zebra's Trust: How Rare Disease Communities' Participation in Data Trusts' Governance Builds Trust and Drives Research

SC Smith - Vand. J. Transnat'l L., 2022 - HeinOnline
Data sharing plays an increasingly prominent role in society, but it remains a necessary
component of rare disease research. Because rare diseases are-as the name indicatesrare …

Influx transporter variants as predictors of cancer chemotherapy-induced toxicity: systematic review and meta-analysis

ZM Zair, DRJ Singer - Pharmacogenomics, 2016 - Future Medicine
Aim: Chemotherapeutic agents have been shown to increase lung patient survival, however
their use may be limited by their serious adverse effects. We aimed to assess int impact of …

Pharmacoepidemiology: A time for a new multidisciplinary approach to precision medicine

AM Issa, B Carleton, T Gerhard… - … and drug safety, 2021 - Wiley Online Library
The advent of the genomic age has created a rapid increase in complexity for the
development and selection of drug treatments. A key component of precision medicine is the …