Results 71 to 80 of about 5,545,002 (288)
The moving boundaries in starting materials: from small molecules to biopharma and ATMPs [PDF]
, 2014 Several guidelines (e.g. ICH) define starting materials for a medicinal drug substance. While a consensus approach for defining the starting material in the synthesis of small molecule API is currently more or less being agreed upon due to the ...
Bracke, Nathalie +2 more
core +1 more source
An empirical analysis of overall survival in drug approvals by the US FDA (2006–2023)
Cancer MedicineBackground The US Food and Drug Administration (FDA) has expanded the use of surrogate markers in drugs approved for oncology/hematology indications. This has likely resulted in a greater number of approvals and possibly drugs coming to market faster ...
Josh Elbaz, Alyson Haslam, Vinay Prasad
doaj +1 more source
In vitro toxicity model: Upgrades to bridge the gap between preclinical and clinical research
Biomolecules & Biomedicine, 2020 The Centers for Disease Control and Prevention (CDC) provides extensive data that indicate our need for drugs to maintain human population health. Despite the substantial availability of drugs on the market, many patients lack specific drugs.
Eneko Madorran +3 more
doaj +1 more source
New Drugs Approved in 2010 [PDF]
Baylor University Medical Center Proceedings, 2011 This article briefly reviews select new drug entities approved by the Food and Drug Administration in 2010.
Tegan Steimel, Erin Sears
openaire +3 more sources
REGULATORY APPROVAL OF NEW MEDICAL DEVICES: A CROSS SECTIONAL STUDY [PDF]
, 2016 Objective To investigate the regulatory approval of new medical devices. Design Cross sectional study of new medical devices reported in the biomedical literature.
Darzi, A +6 more
core +2 more sources
Adverse drug reactions associated with amitriptyline - protocol for a systematic multiple-indication review and meta-analysis [PDF]
, 2020 Background: Unwanted anticholinergic effects are both underestimated and frequently overlooked. Failure to identify adverse drug reactions (ADRs) can lead to prescribing cascades and the unnecessary use of over-thecounter products.
Brueckle, Maria-Sophie +9 more
core +1 more source
Pharmacovigilance and expedited drug approvals [PDF]
Australian Prescriber, 2018 Pharmacovigilance is the detection and assessment of adverse events related to any drug used in clinical practice. In Australia adverse events can be reported to the Therapeutic Goods Administration. Reports are encouraged, even if the drug is old or the prescriber is only suspicious of an adverse event.
Linger, Matthew, Martin, Jennifer
openaire +3 more sources
A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims [PDF]
, 2007 This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why ...
Kessler, David A., Vladeck, David C.
core +1 more source
Clinical and Translational Science, 2023 The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) offer expedited regulatory approval programs for drugs with high potential patient value applicable at different stages leading to marketing authorization: (i) drug ...
Ebru Demirci +2 more
doaj +1 more source