Results 31 to 40 of about 5,351,550 (365)
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
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
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
The importance of greater speed in drug development for advanced malignancies
Cancer Medicine, 2018 It takes on average 6–12 years to develop new anticancer drugs from discovery to approval. Effective new agents prolong survival. To demonstrate the importance of rapid drug approval, we calculated life‐years potentially saved if selected agents were ...
David J. Stewart +9 more
doaj +1 more source
Abiraterone acetate in metastatic castration-resistant prostate cancer after chemotherapy. A retrospective “Real Life” analysis of activity and safety [PDF]
, 2015 Abiraterone acetate (AA) is a potent, selective androge (CYP17) biosynthesis inhibitor, which showed to improve overall survival (HR = 0.646) in mCRPC patients progressing after docetaxel.
A., Giuli +16 more
core +1 more source
Children, 2022 Drugs administered to children in the United States fall into two broad categories: (1) those that have followed the US Food and Drug Administration (US-FDA) pediatric drug approval process and are marketed as finished dosage forms with pediatric ...
Robert B. MacArthur +3 more
doaj +1 more source
Hyperbolic Molecular Representation Learning for Drug Repositioning [PDF]
arXiv, 2022 Learning accurate drug representations is essential for task such as computational drug repositioning. A drug hierarchy is a valuable source that encodes knowledge of relations among drugs in a tree-like structure where drugs that act on the same organs, treat the same disease, or bind to the same biological target are grouped together.
arxiv
Frontiers in Pharmacology, 2021 Several advanced therapy medicinal products (ATMPs) have been approved in the European Union (EU). The aim of this study is to analyse the methodological features of the clinical trials (CT) that supported the marketing authorization (MA) of the approved
Carolina Iglesias-Lopez +5 more
doaj +1 more source