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 …

Wearable smart devices in cancer diagnosis and remote clinical trial monitoring: Transforming the healthcare applications

S Beg, M Handa, R Shukla, M Rahman, WH Almalki… - Drug discovery today, 2022 - Elsevier
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 …

Cancer medicines on the WHO Model List of Essential Medicines: processes, challenges, and a way forward

K Jenei, Z Aziz, C Booth, B Cappello, F Ceppi… - The Lancet Global …, 2022 - thelancet.com
The selection of cancer medicines for national procurement requires deliberate evaluation of
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

KN Vokinger, AS Kesselheim, CEG Glaus… - JAMA Health …, 2022 - jamanetwork.com
Importance The number of drugs approved through the accelerated approval or conditional
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 …

Added therapeutic benefit of top-selling brand-name drugs in Medicare

AC Egilman, BN Rome, AS Kesselheim - JAMA, 2023 - jamanetwork.com
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 …

Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval

ITT Liu, AS Kesselheim, ERS Cliff - JAMA, 2024 - jamanetwork.com
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 …

Cancer treatments should benefit patients: A common-sense revolution in oncology

B Gyawali, CM Booth - Nature Medicine, 2022 - nature.com
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 …

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 …

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 …