Resourcing Drug Development Commensurate With its Public Health Importance

Resourcing Drug Development Commensurate With its Public Health Importance

Bibliographic Details
Main Authors:	Mona Fiuzat, PharmD, Norman Stockbridge, MD, Robert M. Califf, MD
Format:	Article
Language:	English
Published:	Elsevier 2016-08-01
Series:	JACC: Basic to Translational Science
Subjects:	cardiovascular drug development FDA regulation
Online Access:	http://www.sciencedirect.com/science/article/pii/S2452302X16300626

Similar Items

Drugs, Devices, and the FDA: Part 1
by: Gail A. Van Norman, MD
Published: (2016-04-01)

Review of FDA Public Hearing Transcript on Behind-the-Counter Availability of Certain Drugs
by: Reiss, Matthew, et al.
Published: (2009)

Drugs and Devices
by: Gail A. Van Norman, MD
Published: (2016-08-01)

Review of FDA Public Hearing Transcript on Behind-the-Counter Availability of Certain Drugs
by: Rasmussen, Ashli, et al.
Published: (2010)

Information to Improve Public Perceptions of the Food and Drug Administration (FDA’s) Tobacco Regulatory Role
by: Amira Osman, et al.
Published: (2018-04-01)

Resolving shortages of prescription drugs: the case for public-private collaboration
by: Eric Efraim Katz
Published: (2017-05-01)

Why the Watchdog Won’t Bite: U.S. Food and Drug Administration Challenges
by: Joe Lex
Published: (2016-11-01)

Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?
by: Robert Kemp, et al.
Published: (2017-07-01)

The Conundrum of Online Prescription Drug Promotion Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”
by: Isaac Wanasika
Published: (2016-06-01)

One and done: Reasons principal investigators conduct only one FDA-regulated drug trial
by: Amy Corneli, PhD, MPH, et al.
Published: (2017-06-01)

The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs
by: Aviv Ladanie, et al.
Published: (2018-09-01)

Repositioning FDA Drugs as Potential Cruzain Inhibitors from Trypanosoma cruzi: Virtual Screening, In Vitro and In Vivo Studies
by: Isidro Palos, et al.
Published: (2017-06-01)

Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics
by: Ryan D. Rykhus, et al.
Published: (2017-12-01)

Yeast screening platform identifies FDA-approved drugs that reduce Aβ oligomerization
by: Triana Amen, et al.
Published: (2016-03-01)

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis
by: Joshua D. Wallach, et al.
Published: (2019-06-01)

Medicine recalls in Saudi Arabia: a retrospective review of drug alerts (January 2010–January 2019)
by: Bushra T. AlQuadeib, et al.
Published: (2020-11-01)

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies
by: Nguyen Diane, et al.
Published: (2013-01-01)

A Drug Combination Screen Identifies Drugs Active against Amoxicillin-induced Round Bodies of Borrelia burgdorferi Persisters from an FDA Drug Library
by: Jie eFeng, et al.
Published: (2016-05-01)

Fentanyl Overdoses in North America
by: Matt Dias
Published: (2016-04-01)

The regulatory landscape of precision oncology laboratory medicine in the United States – Perspective on the past 5 years and considerations for future regulation
by: Eric Q. Konnick
Published: (2020-08-01)

Prescription drug use during pregnancy in Southern Tigray region, North Ethiopia
by: Fantahun Molla, et al.
Published: (2017-06-01)

Chloroquine, a FDA-approved Drug, Prevents Zika Virus Infection and its Associated Congenital Microcephaly in Mice
by: Chunfeng Li, et al.
Published: (2017-10-01)

Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study
by: Joshua D. Wallach, et al.
Published: (2018-03-01)

Chronological Review and Rational and Future Prospects of Cannabis-Based Drug Development
by: Dvora Namdar, et al.
Published: (2020-10-01)

Regulation of E-Cigarettes in the United States and Its Role in a Youth Epidemic
by: Mark A. Gottlieb
Published: (2019-03-01)

Towards early detection of adverse drug reactions: combining pre-clinical drug structures and post-market safety reports
by: Ruoqi Liu, et al.
Published: (2019-12-01)

Virtual Screening of FDA-Approved Drugs against Triose Phosphate Isomerase from <em>Entamoeba histolytica</em> and <em>Giardia lamblia </em>Identifies Inhibitors of Their Trophozoite Growth Phase
by: Alfredo Juárez-Saldivar, et al.
Published: (2021-05-01)

Clinical Trial and Error: An Assessment of the Food and Drug Administration's Implementation of Breakthrough Therapy Designation
by: Lin, Molly
Published: (2016)

Adverse Effects of Fluoroquinolones: A Retrospective Cohort Study in a South Indian Tertiary Healthcare Facility
by: Benitta Mathews, et al.
Published: (2019-07-01)

Investigating the landscape of US orphan product approvals
by: Kathleen L. Miller, et al.
Published: (2018-10-01)

The Trend of Voluntary Warnings in Electronic Nicotine Delivery System Magazine Advertisements
by: Ce Shang, et al.
Published: (2017-01-01)

Identification of Additional Anti-Persister Activity against Borrelia burgdorferi from an FDA Drug Library
by: Jie Feng, et al.
Published: (2015-09-01)

PROMOTING BREAKTHROUGH MEDICAL INNOVATION: INSIGHTS FROM AN ANALYSIS OF RECENT TRANSFORMATIVE DRUGS, BIOLOGICS AND MEDICAL DEVICES
by: Xu, Shuai
Published: (2014)

A Summary of the United States Food and Drug Administrations’ Food Safety Program for Imported Seafood; One Country’s Approach
by: Brett Koonse
Published: (2016-04-01)

Acrylamide in Food – EU versus FDA Approaches
by: Gabriel Mustăţea, et al.
Published: (2015-11-01)

Patterns and determinants of prescribed drug use among pregnant women in Adigrat general hospital, northern Ethiopia: a cross-sectional study
by: Niguse Meles Alema, et al.
Published: (2020-10-01)

Retrospective evaluation of single patient investigational new drug (IND) requests in pediatric oncology
by: David S. Shulman, et al.
Published: (2021-04-01)

Bioaccumulation of heavy metals, Ni, Cd and Pb in muscle, liver and caviar of farmed Acipenser baerii from Khuozestan Province
by: A Mohammad Salehi; Velayatzadeh Velayatzadeh; N Karami Rad
Published: (2017-01-01)

Evaluation of the accordance of panoramic radiography ordering in maxillofacial radiology department, school of dentistry, Tehran university of medical sciences with FDA guidelines in scholar year 200
by: Goodarzi Pour D., et al.
Published: (2007-07-01)

Pharma, Prescription Opioids, and Heroin Plague—Where We are Now.
by: Stephanie Holmquist
Published: (2015-08-01)