Real-world evaluation of interstitial lung disease/pneumonitis in patients treated with trastuzumab deruxtecan for HER2-positive advanced or recurrent gastric cancer: a postmarketing surveillance study in Japan. [PDF]
Kawakami H +3 more
europepmc +1 more source
Getting There First With the Best: The Need to Shorten the Prescription Drug Approval Process [PDF]
Kassel, Mark A.
core +1 more source
Specificity of Food and Drug Administration postmarketing requirements and associations with timely submissions and regulatory decisions for oncology accelerated approvals, 2011-2023: a cross-sectional analysis. [PDF]
Kurian M +7 more
europepmc +1 more source
Pragmatic implementation of intravascular lithotripsy in Japan based on the guidelines for proper use. [PDF]
Shiba T +6 more
europepmc +1 more source
Flexibility over rigor: stakeholder acceptance of the limitations of confirmatory studies following accelerated approval. [PDF]
Fernandez Lynch H +4 more
europepmc +1 more source
Cumulative review of cardiac failure with acalabrutinib in the treatment of chronic lymphocytic leukemia using data from clinical trials and postmarketing experience. [PDF]
Ghia P +5 more
europepmc +1 more source
MGB3 Postmarketing Outcomes Studies: Benefits And Risks
FB Garfield, JJ Caro
openalex +1 more source
Artificial Intelligence in Clinical and Translational Science: From Bench Insights to Bedside Impact. [PDF]
Shahin MH, Liu Q.
europepmc +1 more source

