Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy
DT Michaeli, T Michaeli, S Albers, T Boch… - The European Journal of …, 2024 - Springer
Background Over the past decades, US Congress enabled the US Food and Drug
Administration (FDA) to facilitate and expedite drug development for serious conditions …
Administration (FDA) to facilitate and expedite drug development for serious conditions …
Wearable smart devices in cancer diagnosis and remote clinical trial monitoring: Transforming the healthcare applications
Highlights•Wearable devices are intelligent tools of 21st century modern healthcare
systems.•Early diagnosis of cancer is the only key decisive factor to start the drug …
systems.•Early diagnosis of cancer is the only key decisive factor to start the drug …
Cancer medicines on the WHO Model List of Essential Medicines: processes, challenges, and a way forward
The selection of cancer medicines for national procurement requires deliberate evaluation of
population benefit, budget impact, sustainability, and health system capacity. However, this …
population benefit, budget impact, sustainability, and health system capacity. However, this …
[HTML][HTML] Therapeutic value of drugs granted accelerated approval or conditional marketing authorization in the US and Europe from 2007 to 2021
Importance The number of drugs approved through the accelerated approval or conditional
marketing authorization pathways has increased with unclear evidence of their therapeutic …
marketing authorization pathways has increased with unclear evidence of their therapeutic …
Evidence of pre-approval clinical trial supporting the granted conditional approval for novel cancer drugs in China between 2015 and 2022
X Luo, X Du, L Huang, Q Guo, X Lv, C Wang… - …, 2023 - thelancet.com
Background Accelerated approval (AA) of novel anticancer drugs based on surrogacy has
attracted considerable concern globally. China National Medical Products Administration …
attracted considerable concern globally. China National Medical Products Administration …
Added therapeutic benefit of top-selling brand-name drugs in Medicare
Importance The Inflation Reduction Act of 2022 authorizes Medicare to negotiate prices of
top-selling drugs based on several factors, including therapeutic benefit compared with …
top-selling drugs based on several factors, including therapeutic benefit compared with …
Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval
Importance The US Food and Drug Administration's (FDA) accelerated approval pathway
allows approval of investigational drugs treating unmet medical needs based on changes to …
allows approval of investigational drugs treating unmet medical needs based on changes to …
Cancer treatments should benefit patients: A common-sense revolution in oncology
Cancer treatments should benefit patients: a common-sense revolution in oncology | Nature
Medicine Skip to main content Thank you for visiting nature.com. You are using a browser version …
Medicine Skip to main content Thank you for visiting nature.com. You are using a browser version …
National comprehensive cancer network guideline recommendations of cancer drugs with accelerated approval
ERS Cliff, RS Rome, AS Kesselheim… - JAMA Network …, 2023 - jamanetwork.com
Importance Many cancer drugs are approved under the US Food and Drug Administration
(FDA) accelerated approval pathway based on preliminary evidence. It is unclear how this …
(FDA) accelerated approval pathway based on preliminary evidence. It is unclear how this …
The price, efficacy, and safety of within-class targeted anticancer medicines between domestic and imported drugs in China: a comparative analysis
X Luo, X Du, L Huang, Q Guo, R Tan… - The Lancet Regional …, 2023 - thelancet.com
Background Affordability to novel anticancer drugs has become a major health issue in
China. It is encouraging to note that China initiated its drug regulatory reform and national …
China. It is encouraging to note that China initiated its drug regulatory reform and national …