Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice
RA Deyo - The Journal of the American Board of Family …, 2004 - Am Board Family Med
Despite many successes, drug approval at the Food and Drug Administration (FDA) is
subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and …
subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and …
Drugs, devices, and the FDA: part 2: an overview of approval processes: FDA approval of medical devices
GA Van Norman - JACC: Basic to Translational Science, 2016 - jacc.org
As with new drugs, the US Food and Drug Administration's approval process is intended to
provide consumers with assurance that, once it reaches the market place, a medical device …
provide consumers with assurance that, once it reaches the market place, a medical device …
Building comparative efficacy and tolerability into the FDA approval process
AB O'Connor - Jama, 2010 - jamanetwork.com
THE US FOOD AND DRUG ADMINISTRATION (FDA)“IS responsible for protecting the
public health by as-suring the safety, efficacy, and security” of drugs and medical devices …
public health by as-suring the safety, efficacy, and security” of drugs and medical devices …
Drugs, devices, and the FDA: part 1: an overview of approval processes for drugs
GA Van Norman - JACC: Basic to Translational Science, 2016 - jacc.org
Over the last 150 years, the US Food and Drug Administration (FDA) has evolved from a
small division of the US Patent Office to 1 of the largest consumer protection agencies in the …
small division of the US Patent Office to 1 of the largest consumer protection agencies in the …
[PDF][PDF] Review of the processes for FDA oversight of drugs, medical devices, and combination products
BV Sweet, AK Schwemm, DM Parsons - Journal of Managed Care …, 2011 - jmcp.org
■■ Methods A MEDLINE search (1950 to September 2010) for Englishlanguage articles
was conducted using the following search terms: drug approval, device approval …
was conducted using the following search terms: drug approval, device approval …
Opening the FDA black box
SN Goodman, RF Redberg - JAMA, 2014 - jamanetwork.com
The US Food and Drug Administration (FDA) is sometimes described as the most powerful
regulatory agency in the world, its decisions affecting billions of both lives and dollars. The …
regulatory agency in the world, its decisions affecting billions of both lives and dollars. The …
Trends in the quality of evidence supporting FDA drug approvals: results from a literature review
BL Brown, M Mitra-Majumdar, K Joyce… - Journal of Health …, 2022 - read.dukeupress.edu
Context: New drug approvals in the United States must be supported by substantial
evidence from “adequate and well-controlled” trials. The Food and Drug Administration …
evidence from “adequate and well-controlled” trials. The Food and Drug Administration …
[HTML][HTML] User fees and beyond—the FDA Safety and Innovation Act of 2012
DB Kramer, AS Kesselheim - New England Journal of Medicine, 2012 - Mass Medical Soc
User Fees and Beyond — The FDA Safety and Innovation Act of 2012 | NEJM Skip to main
content NEJM Group Follow Us Facebook Twitter Instagram YouTube LinkedIn Prepare to …
content NEJM Group Follow Us Facebook Twitter Instagram YouTube LinkedIn Prepare to …
A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report
BM Psaty, EM Meslin, A Breckenridge - Jama, 2012 - jamanetwork.com
IN THE POSTMARKET SETTING, THE REGULATION OF MEDICINES requires an
assessment of the balance between their ben-efits and risks and, as new information …
assessment of the balance between their ben-efits and risks and, as new information …
From idea to market: the drug approval process.
BACKGROUND Each year many new prescription drugs are approved by the Food and
Drug Administration (FDA). The process of developing and bringing new drugs to market is …
Drug Administration (FDA). The process of developing and bringing new drugs to market is …