Results 21 to 30 of about 4,498,317 (372)
Pharmacy, 2022 The “breakthrough therapy” designation (BTD) is a recent mechanism implemented by the United States Food and Drug Administration (FDA) to expedite access to drugs that address unmet needs.
Megan C. Herink +4 more
doaj +1 more source
bioRxiv, 2019 Despite strong vetting for disease activity, only 10% of candidate new molecular entities in early stage clinical trials are eventually approved. Analyzing historical pipeline data, Nelson et al. 2015 (Nat.
E. King, J. W. Davis, Jacob F. Degner
semanticscholar +1 more source
Overcoming the Declining Trends in Innovation and Investment in Cardiovascular Therapeutics
JACC: Basic to Translational Science, 2017 Eroom’s law (Moore’s law spelled backwards), describes adverse trends towards declining innovation and rising costs of drug development over the last several decades.
Gail A. Van Norman, MD
doaj +1 more source
The drug approval tactician [PDF]
Nature Reviews Drug Discovery, 2003 Regulatory affairs in the pharmaceutical industry is both a familiar and unfamiliar world. The industry is well known as being one of the most highly regulated, revolving around the approval of new compounds that emerge from the drug development pipeline by national or multinational regulatory bodies.
openaire +3 more sources
the congenital disorders of glycosylation community perspective [PDF]
, 2022 BACKGROUND: Congenital disorders of glycosylation (CDG) are a large family of rare genetic diseases for which therapies are virtually nonexistent. However, CDG therapeutic research has been expanding, thanks to the continuous efforts of the CDG medical ...
Brasil, Sandra +8 more
core +5 more sources
Product Complexity and Strategic Alliance on Drug Approval
American Business Review, 2021 Management of the business-government relationship is critical for firm performance in regulated industries. In this paper, we predict a U-shaped relationship between product complexity and the time to approval by the US Food and Drug Administration (FDA)
Taoyong Su +3 more
doaj +1 more source
JAMA Internal Medicine, 2021 Key Points Question Are cancer drugs granted accelerated approval from the US Food and Drug Administration (FDA) recommended for funding through the National Health Service (NHS) in England?
Avi Cherla +4 more
semanticscholar +1 more source
JACC: Basic to Translational Science, 2016 The regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative therapies through the investigative and regulatory processes as quickly as possible.
Gail A. Van Norman, MD
doaj +1 more source
Evidence of comparative efficacy should have a formal role in European drug approvals [PDF]
, 2011 Despite methodological concerns, comparative efficacy evidence should be required at the time of drug approval, says Corinna Sorenson and colleagues, to allow patients, clinicians, and other healthcare decision makers to determine whether a new drug is ...
Cylus, Jonathan +3 more
core +1 more source
Trends in FDA drug approvals over last 2 decades: An observational study
Journal of Family Medicine and Primary Care, 2020 Introduction: The discovery of novel drugs is critical for pharmaceutical research and development as well as for patient treatment. Repurposing existing drugs that may have anticipated effects as potential candidate is one way to meet this important ...
Angelika Batta +2 more
doaj +1 more source