Topics

FDA Approval and Regulation of Pharmaceuticals, 1983-2018.

07:00 EST 14th January 2020 | BioPortfolio

Summary of "FDA Approval and Regulation of Pharmaceuticals, 1983-2018."

US law requires testing of new drugs before approval to ensure that they provide a well-defined benefit that is commensurate with their risks. A major challenge for the US Food and Drug Administration (FDA) is to achieve an appropriate balance between rigorous testing and the need for timely approval of drugs that have benefits that outweigh their risks.

Affiliation

Journal Details

This article was published in the following journal.

Name: JAMA
ISSN: 1538-3598
Pages: 164-176

Links

DeepDyve research library

PubMed Articles [7954 Associated PubMed Articles listed on BioPortfolio]

Comparison of the regulatory outline of ecopharmacovigilance of pharmaceuticals in Europe, USA, Japan and Australia.

Pharmaceuticals are known to improve the quality of life by curing and preventing diseases. However, these pharmaceutical products, when it diffuses through the environment by various routes, can caus...

Walter Mischel (1930-2018).

This article memorializes Walter Mischel (1930 -2018). Mischel was a professor at the University of Colorado (1956 -1958), Harvard University (1958 -1962), Stanford University (1962-1983), and Columbi...

Mytilidae as model organisms in the marine ecotoxicology of pharmaceuticals - A review.

Growing production and consumption of pharmaceuticals is a global problem. Due to insufficient data on the concentration and distribution of pharmaceuticals in the marine environment, there are no app...

Occurrence and ranking of pharmaceuticals in the major rivers of China.

Residual pharmaceuticals have received widespread attention worldwide due to their continuous release and potential hazard to the environment. As a result of rapid development and a large population, ...

Analysis, occurrence and removal of pharmaceuticals in African water resources: A current status.

Pharmaceuticals are organic compounds used in medicines for alleviation of pain. Since 2017, there has been a steady increase on the availability of information on contamination of water resources cau...

Clinical Trials [2504 Associated Clinical Trials listed on BioPortfolio]

Study of a Cohort of Cases of Synovial Sarcoma Treated in the Orthopedic Surgery and Traumatology Department of the Hospital de Sant Pau Between 1983 and 2016

The main objectives of this study are the following: to describe the prognostic factors of survival of synovial sarcoma in patients treated by the orthopedic surgery unit oncologic of the ...

Effect of InnoSlim® on Blood Sugar and Blood Lipids Regulation in Humans

InnoSlim® has been studied for enhancing metabolic functions whereas many lab studies have demonstrated the potential efficacy of InnoSlim® for the blood sugar and blood lipids regulatio...

Bioequivalence Study of Torrent Pharmaceuticals Ltd's Nebivolol 20 mg Tablet

Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and Bystolic®20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were sep...

Bioequivalence Study of Torrent Pharmaceuticals's Ltd's Nebivolol 20 mg Tablet

Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and Bystolic 20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were sepa...

Post PMA-Approval Study: New Enrollment Post PMA-Approval Study Post-approval Study Group (New Enrollment)

The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.

Medical and Biotech [MESH] Definitions

Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.

Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.

The process of gaining approval by a government regulatory agency for DIAGNOSTIC REAGENTS AND TEST KITS. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance.

Control of drug and narcotic use by international agreement, or by institutional systems for handling prescribed drugs. This includes regulations concerned with the manufacturing, dispensing, approval (DRUG APPROVAL), and marketing of drugs.

The attitude that grants freedom of expression and activity to another individual, but not necessarily with sanction or approval.

Quick Search


DeepDyve research library

Relevant Topic

BioPortfolio - life science, medical devices and pharmaceutical conference
BioPortfolio is a leading news, information and knowledge resource covering the global life science industries impacted on by biotechnology. The site aims to provide the lay person, the researcher and the management executive with a single location to so...


Searches Linking to this Article