Results 31 to 40 of about 953,056 (326)
Реальная клиническая практика: данные и доказательства, 2023 In 2021, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of electronic health records and medical claims data for regulatory decisions.
Ksenia S. Radaeva, M. V. Pchelintsev
doaj +1 more source
Regulating Innovative Medicine: Fitting Square Pegs in Round Holes [PDF]
, 2005 Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration ( FDA ) because they often transcend the FDA\u27s traditional categorical approach to regulating medical products. In a recent attempt to simplify this
Lavender, Mark
core +1 more source
The FDA “black box” warning on antidepressant suicide risk in young adults: More harm than benefits? [PDF]
, 2019 The decision made in the year 2004 by the U.S. Food and Drug Administration (FDA) to require a boxed warning on antidepressants regarding the risk of suicidality in young adults still represents a matter of controversy.
Anastasia A. +12 more
core +1 more source
FEBS Letters, EarlyView.Cryptochrome and PAS/LOV proteins play intricate roles in circadian clocks where they act as both sensors and mediators of protein–protein interactions. Their ubiquitous presence in signaling networks has positioned them as targets for small‐molecule therapeutics. This review provides a structural introduction to these protein families.
Eric D. Brinckman +2 more
wiley +1 more source
Cell wall target fragment discovery using a low‐cost, minimal fragment library
FEBS Letters, EarlyView.LoCoFrag100 is a fragment library made up of 100 different compounds. Similarity between the fragments is minimized and 10 different fragments are mixed into a single cocktail, which is soaked to protein crystals. These crystals are analysed by X‐ray crystallography, revealing the binding modes of the bound fragment ligands.
Kaizhou Yan +5 more
wiley +1 more source
Valuation implications of pharmaceutical companies' R&D regulatory approval notifications [PDF]
, 2013 This paper examines shareholder wealth effects surrounding applications to, and approvals by, the United States Food and Drug Administration (FDA) for firms listed on the New York (NYSE) and London (LSE) stock exchanges.
Hamill, P.A., McIlkenny, P., Opong, K.K.
core +1 more source
Mechanisms of IgE‐mediated food allergy and the role of allergen‐specific B cells
FEBS Letters, EarlyView.Food allergy arises when allergen‐specific B cells preferentially produce immunoglobulin E (IgE) antibodies against harmless foods. This article explains the mechanisms driving IgE‐mediated reactions, highlights the central role of these B cells, and discusses how natural tolerance (NT) and oral immunotherapy (OIT) can reshape allergic immune responses.
Juan‐Felipe López +2 more
wiley +1 more source
npj VaccinesNeonates and young infants are known to have limited responses to pediatric vaccines due to reduced germinal center formation. Extended vaccine antigen dosing was previously shown to expand germinal center formation and improve humoral responses in adult
Leda Lotspeich-Cole +6 more
doaj +1 more source
Valid cardiac biochemical markers. Part II
Кардиоваскулярная терапия и профилактика, 2020 This publication is a continuation of the review of cardiac biomarkers approved by the Food and Drug Administration (USA), including analysis of prospective research, clinical trials and meta-analyses.
N. G. Gumanova +4 more
doaj +1 more source
\u3ci\u3eUnited States v. Caronia\u3c/i\u3e: Off-Label Drug Promotion and First Amendment Balancing [PDF]
, 2018 Off-label drug promotion is commonplace in the United States, but it is not without its dangers. While the Food, Drug, and Cosmetic Act does not explicitly ban off-label promotion, the Food & Drug Administration (FDA)— in order to protect consumers from ...
Rabinowitz, Daniel P.
core +1 more source