Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016.
Sign Up to like & getrecommendations! Published in 2022 at "JAMA internal medicine"
DOI: 10.1001/jamainternmed.2022.4226
Abstract: This cohort study used the Drugs@FDA database to identify new drugs approved by the US Food and Drug Administration (FDA) and assess fulfillment of postmarket commitments and requirements. read more here.
Keywords: new drugs; fda; drugs approved; postmarket commitments ... See more keywords
Fluorescein diacetate (FDA) and its analogue as substrates for Pi-class glutathione S-transferase (GSTP1) and their biological application.
Sign Up to like & getrecommendations! Published in 2018 at "Talanta"
DOI: 10.1016/j.talanta.2017.12.010
Abstract: Pi class glutathione S-transferase (GSTP1) is highly expressed in various cancerous cells and pre-neoplastic legions, where it is involved in apoptotic resistance or metabolism of several anti-tumour chemotherapeutics. Therefore, GSTP1 is a marker of malignant… read more here.
Keywords: transferase gstp1; gstp1; class glutathione; fluorescein ... See more keywords
FDA ovarian cancer clinical trial endpoints workshop: A Society of Gynecologic Oncology White Paper.
Sign Up to like & getrecommendations! Published in 2017 at "Gynecologic oncology"
DOI: 10.1016/j.ygyno.2017.08.012
Abstract: a University of Cincinnati Cancer Institute, Dept. of Ob/Gyn, University of Cincinnati, United States b Office of Hematology Oncology Products, OND, CDER, FDA, United States c Division of Gynecologic Oncology, Department of Obstetrics and Gynecology,… read more here.
Keywords: ovarian cancer; united states; gynecologic oncology; oncology ... See more keywords
The United States must act quickly to control the use of e-cigarettes
Sign Up to like & getrecommendations! Published in 2017 at "Nature"
DOI: 10.1038/nature.2017.21987
Abstract: innovation in the sector: why develop a new product, or fix a flaw in an old one, if it will cost your company hundreds of thousands of dollars to have it approved? So if Congress… read more here.
Keywords: use cigarettes; industry; public health; cigarette ... See more keywords
FDA approves first single-dose antimalarial
Sign Up to like & getrecommendations! Published in 2018 at "Nature Biotechnology"
DOI: 10.1038/nbt0918-785a
Abstract: On July 20, the US Food and Drug Administration approved GlaxoSmithKline’s Krintafel (tafenoquine), a single-dose treatment to prevent relapses of Plasmodium vivax, a malaria parasite that causes more than eight million infections annually. “This drug… read more here.
Keywords: malaria parasite; krintafel; drug; blood ... See more keywords
FDA approves dupilumab for severe eczema
Sign Up to like & getrecommendations! Published in 2017 at "Nature Reviews Drug Discovery"
DOI: 10.1038/nrd.2017.90
Abstract: The new contender seems to offer a lower risk of depression, somnolence and akathisia than the established competition. It still carries a black box warning, however, citing the risk of depression and suicidality. Teva, which… read more here.
Keywords: fda approves; drug; dupilumab severe; approves dupilumab ... See more keywords
Transmit Beampattern Synthesis for the FDA Radar
Sign Up to like & getrecommendations! Published in 2018 at "IEEE Antennas and Wireless Propagation Letters"
DOI: 10.1109/lawp.2017.2776957
Abstract: The frequency diverse array (FDA) radar has drawn great attention due to the periodicity of the beampattern in range, angle, and time. In this letter, we restudy the recent work that designed a time-invariant beampattern… read more here.
Keywords: beampattern synthesis; fda radar; fda; transmit beampattern ... See more keywords
When science and politics collide: Enhancing the FDA
Sign Up to like & getrecommendations! Published in 2019 at "Science"
DOI: 10.1126/science.aaw8093
Abstract: Science-based decisions on drug safety are threatened by political interference For the better part of a century, the U.S. Food and Drug Administration (FDA) preserved public health by rigorously applying the scientific method. The central… read more here.
Keywords: science; drug; politics collide; collide enhancing ... See more keywords
Flexibility and innovation in the FDA's novel regulatory approval strategies for hematologic drugs.
Sign Up to like & getrecommendations! Published in 2017 at "Blood"
DOI: 10.1182/blood-2017-04-742726
Abstract: The US Food and Drug Administration (FDA) negotiates the evidence necessary for drug approval with pharmaceutical sponsors. The resulting data package submitted in support of approval includes labeling that conveys the benefits and risks of… read more here.
Keywords: flexibility innovation; innovation fda; novel regulatory; fda novel ... See more keywords
Airborne FDA-MIMO Radar Modeling and Detection Performance Analysis
Sign Up to like & getrecommendations! Published in 2021 at "Radioengineering"
DOI: 10.13164/re.2021.0396
Abstract: In the conventional frequency diverse array (FDA) radar designs, generalized likelihood ratio test (GLRT) detection utilizes coherent pulses. However, the impacts of an FDA multiple-input multiple-output (FDAMIMO) radar system for detection with incoherent pulses have… read more here.
Keywords: fda; performance; fda mimo; mimo radar ... See more keywords
A Systematic Review of U.S. Biosimilar Approvals: What Evidence Does the FDA Require and How Are Manufacturers Responding?
Sign Up to like & getrecommendations! Published in 2017 at "Journal of managed care & specialty pharmacy"
DOI: 10.18553/jmcp.2017.23.12.1234
Abstract: BACKGROUND Biosimilars undergo an abbreviated licensure pathway called 351(k), which was created by the Biologics Price Competition and Innovation Act of 2009. This approval process is different from the 351(a) pathway for original biologic approval… read more here.
Keywords: clinical studies; reference product; evidence; united states ... See more keywords