scholarly journals The law on cardiovascular devices: the role of the Food and Drug Administration and physicians in its implementation.

Circulation ◽  
1980 ◽  
Vol 62 (5) ◽  
pp. 919-924 ◽  
Author(s):  
S H Rahimtoola ◽  
G A Rahmoeller
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Cardiovascular Devices ◽  
The Law

Abstract 17056: Food and Drug Administration Mandated Post-Market Studies for High Risk Cardiovascular Devices Approved 2015-2019

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Danelle Hidano ◽  
Sanket Dhruva ◽  
Rita F Redberg
Keyword(s):  
High Risk ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Included Study ◽  
Life Cycle Approach ◽  
Cardiovascular Devices ◽  
Study Duration ◽  
Number Of Patients ◽  
Data Elements ◽  
Double Blinded

Introduction: The Food and Drug Administration (FDA) emphasizes a “life-cycle approach” to medical device regulation, in which the pre-approval process is expedited and more emphasis is placed on post-approval data in order to shorten patient access to new devices. The FDA can mandate post approval studies (PASs) for high-risk devices to augment pre-approval data. This study describes the characteristics of FDA-mandated PASs. Methods: We searched the FDA database for all PASs required for original high-risk cardiovascular devices approved from January 1, 2015 and December 31, 2019. Data elements abstracted for each PAS included: study type, presence of controls, blinding, total number of patients enrolled, study duration, and whether primary outcomes were surrogate or composite measures. We also checked the FDA website for any available interim data prior to study completion. Results: The FDA approved 71 high-risk cardiovascular devices and ordered a total of 68 PASs for 49 (69%) devices. Most PASs were prospective cohorts (n=47, 69.1%). The median study size was 250 patients (IQR 151-563) and median study duration was 5 years (IQR 3-5). Only 19 studies (28%) included active or historic controls, 12 studies (17.7%) were randomized, 5 studies (7.3%) were single-blinded, and none were double-blinded (Table). Twenty-two (32.4%) studies provided data before completion of study. Conclusion: Most PAS are not randomized, lack controls, contain small numbers of patients, and have composite or surrogate primary outcomes that may not be clinically relevant, despite their importance for generating long-term clinical data for high-risk cardiovascular devices. Interim data are often not available. Increased quality and availability of evidence related to PASs would better establish device safety, effectiveness, and appropriate use. Lastly, PAS data should be readily accessible to help clinicians and patients make well-informed decisions.

The Role of the USA Food and Drug Administration in Clinical Research

2014 ◽  
pp. 117-143
Author(s):  
Stephen P. Glasser ◽  
Carol M. Ashton ◽  
Nelda P. Wray
Keyword(s):  
Clinical Research ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The Usa

Regulation of Compounding by the Food and Drug Administration

2010 ◽  
Vol 23 (5) ◽  
pp. 502-506 ◽  
Author(s):  
Karl G. Williams
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Pharmacy Practice ◽  
Federal Regulation ◽  
Traditional Art ◽  
The Law ◽  
State Of Affairs

Federal regulation of the traditional art of pharmacy practice compounding is an unsettled area of the law and the profession. For many years, the Food and Drug Administration (FDA) was not interested in compounding. Attempts to regulate by FDA and Congress have caused difficulty within the profession, litigation with inconsistent results, and an unsettled state of affairs. There are a number of possible resolutions.

scholarly journals Poly-ADP-ribose polymerase inhibitor use in ovarian cancer: expanding indications and novel combination strategies

2019 ◽  
Vol 29 (5) ◽  
pp. 956-968 ◽  
Author(s):  
Emily Hinchcliff ◽  
Shannon Neville Westin ◽  
Graziela Dal Molin ◽  
Christopher J LaFargue ◽  
Robert L. Coleman
Keyword(s):  
Ovarian Cancer ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Parp Inhibitors ◽  
Parp Inhibition ◽  
Combination Therapies ◽  
Combination Strategies ◽  
Polymerase Inhibitor

The use of poly(ADP-ribose) polymerase (PARP) inhibition is transforming care for the treatment of ovarian cancer, with three different PARP inhibitors (PARPi) gaining US Food and Drug Administration approval since 2014. Given the rapidly expanding use of PARPi, this review aims to summarize the key evidence for their use and therapeutic indications. Furthermore, we provide an overview of the development of PARPi resistance and the emerging role of PARPi combination therapies, including those with anti-angiogenic and immunotherapeutic agents.

scholarly journals Predicting Mortality with Applied Machine Learning: Can We Get There?

2019 ◽  
Vol 8 (1) ◽  
pp. 115-119
Author(s):  
Emily S. Patterson ◽  
C.J. Hansen ◽  
Theodore T. Allen ◽  
Qiwei Yang ◽  
Susan D. Moffatt-Bruce
Keyword(s):  
Machine Learning ◽  
Decision Making ◽  
Real Time ◽  
Drug Administration ◽  
Patient Population ◽  
Food And Drug Administration ◽  
Hospital Environment ◽  
Clinical Settings ◽  
Applied Machine Learning

There is growing interest in using AI-based algorithms to support clinician decision-making. An important consideration is how transparent complex algorithms can be for predictions, particularly with respect to imminent mortality in a hospital environment. Understanding the basis of predictions, the process used to generate models and recommendations, how to generalize models based on one patient population to another, and the role of oversight organizations such as the Food and Drug Administration are important topics. In this paper, we debate opposing positions regarding whether these algorithms are ‘ready yet’ for use today in clinical settings for physicians, patients and caregivers. We report voting results from participating audience members in attendance at the conference debate for each of these positions obtained real-time from a smartphone-based platform.

The Statistics of Nutrition Sampling and Analysis

1974 ◽  
Vol 57 (5) ◽  
pp. 1181-1189
Author(s):  
Howard R Roberts
Keyword(s):  
Drug Administration ◽  
Natural Variation ◽  
Food And Drug Administration ◽  
Nutrient Content ◽  
Nutrition Labeling ◽  
Critical Importance ◽  
Analytical Methodology ◽  
Labeling Regulations ◽  
Analytical Variation

Abstract It is widely recognized that there is natural variation in the nutrient content of food products. When one attempts to measure nutrient levels, another source of variation becomes apparent—that inherent in the measurement process itself. Analytical variation is, of course, apparent when different methods are used but can also occur with the same method because of differences among laboratories and/or analysts. Both in its own right and more especially with regard to evaluating compliance with labeling regulations, method variability is of critical importance. In order to appreciate the role of analytical methodology, the nutrition labeling regulations and the procedures by which the Food and Drug Administration will assess compliance must first be thoroughly understood. This paper is directed toward that understanding.

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