Results 21 to 30 of about 5,628,754 (380)
The use of mechanistic evidence in drug approval. [PDF]
J Eval Clin Pract, 2018 The role of mechanistic evidence tends to be under‐appreciated in current evidence‐based medicine (EBM), which focusses on clinical studies, tending to restrict attention to randomized controlled studies (RCTs) when they are available. The EBM+ programme
Aronson JK +4 more
europepmc +2 more sources
The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: Report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group [PDF]
, 2018 Expedited pathways to antimicrobial agent approval by the U.S. Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices.
Burnham, Carey-Ann D +6 more
core +2 more sources
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
Revista Panamericana de Salud Pública, 2022 Objectives. To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods. An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin ...
Ivar T. van der Zee +3 more
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
Disclosure of Clinical Trial Data: Why Exemption 4 of the Freedom of Information Act Should Be Restored [PDF]
, 2005 Clinical trial data generated during the FDA drug approval process can be very valuable. While patients and doctors desperately need this information to make informed choices about medical treatment, drug sponsors strive to keep this resource secret to ...
Boyce, Janene
core +3 more sources
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
Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process. [PDF]
J Manag Care Spec Pharm, 2017 Mattingly TJ, Simoni-Wastila L.
europepmc +2 more sources
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 +2 more sources
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