Brief overview of approaches and challenges in new antibiotic development: a focus on drug repurposing
Drug repurposing, or identifying new uses for existing drugs, has emerged as an alternative
to traditional drug discovery processes involving de novo synthesis. Drugs that are currently …
to traditional drug discovery processes involving de novo synthesis. Drugs that are currently …
Generating comparative evidence on new drugs and devices before approval
Fewer than half of new drugs have data on their comparative benefits and harms against
existing treatment options at the time of regulatory approval in Europe and the USA. Even …
existing treatment options at the time of regulatory approval in Europe and the USA. Even …
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
TJ Hwang, JS Ross, KN Vokinger, AS Kesselheim - bmj, 2020 - bmj.com
Objective To characterize the therapeutic value of new drugs approved by the US Food and
Drug Administration (FDA) and European Medicines Agency (EMA) and the association …
Drug Administration (FDA) and European Medicines Agency (EMA) and the association …
Speed of adoption of immune checkpoint inhibitors of programmed cell death 1 protein and comparison of patient ages in clinical practice vs pivotal clinical trials
JM O'Connor, KL Fessele, J Steiner… - JAMA …, 2018 - jamanetwork.com
Importance The US Food and Drug Administration (FDA) is increasing its pace of approvals
for novel cancer therapeutics, including for immune checkpoint inhibitors of programmed cell …
for novel cancer therapeutics, including for immune checkpoint inhibitors of programmed cell …
Real-world evidence for coverage decisions: opportunities and challenges
G Hampson, A Towse, WB Dreitlein… - Journal of …, 2018 - becarispublishing.com
Aim: To explore current uses of real-world evidence (RWE) in the US healthcare system,
summarize key concerns and highlight various opportunities that could be realized through …
summarize key concerns and highlight various opportunities that could be realized through …
Clinical benefit and expedited approval of cancer drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia
PURPOSE: Regulatory agencies have sought to speed up the review of new cancer
medicines and reduce delays in approval between countries. We examined trends in …
medicines and reduce delays in approval between countries. We examined trends in …
NICE's new methods: putting innovation first, but at what cost?
V Charlton, J Lomas, P Mitchell - bmj, 2022 - bmj.com
Traditionally the gatekeeper to the NHS, NICE has increasingly reoriented its role towards
facilitating access to innovative technologies. This change has clear benefits for some …
facilitating access to innovative technologies. This change has clear benefits for some …
Use of US Food and Drug Administration expedited drug development and review programs by orphan and nonorphan novel drugs approved from 2008 to 2021
AN Monge, DW Sigelman, RJ Temple… - JAMA Network …, 2022 - jamanetwork.com
Importance The US Food and Drug Administration (FDA) has 4 programs that can be used
alone or in combination to expedite drug availability: Accelerated Approval, Breakthrough …
alone or in combination to expedite drug availability: Accelerated Approval, Breakthrough …
[HTML][HTML] Promoting innovation while controlling cost: the UK's approach to health technology assessment
New technologies, including pharmaceuticals and medical devices, can improve treatment
options in healthcare but also bring concerns about rising healthcare costs. We undertake a …
options in healthcare but also bring concerns about rising healthcare costs. We undertake a …
The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements
The US Food and Drug Administration has several regulatory programs and pathways to
expedite the development and approval of therapeutic agents aimed at treating serious or …
expedite the development and approval of therapeutic agents aimed at treating serious or …