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Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA’s De Novo pathway

2024 . Aboy, Mateo | Crespo, Cristina | Stern, Ariel Dora

Progression-free survival as a surrogate endpoint in myeloma clinical trials: an evolving paradigm

2024 . Pawlyn, Charlotte | Schjesvold, Fredrik | Cairns, David | Wei, L. J. | Davies, Faith | Nadeem, Omar | Abdulhaq, Haifaa | Mateos, María-Victoria | Laubach, Jacob | Weisel, Katja | Ludwig, Heinz | Rajkumar, S. Vincent | Sonneveld, Pieter | Jackson, Graham | Morgan, Gareth | Richardson, Paul

Comparative effectiveness of alternative intervals between first and second doses of the mRNA COVID-19 vaccines

2024 . Shioda, Kayoko | Breskin, Alexander | Harati, Pravara | Chamberlain, Allison T. | Komura, Toshiaki | Lopman, Benjamin A. | Rogawski McQuade, Elizabeth Tacket

Patient Enrollment per Month (Accrual) in Clinical Trials Leading to the FDA Approval of New Cancer Drugs

2024 . Michaeli, Daniel Tobias | Michaeli, Christoph | Albers, Sebastian | Michaeli, Julia Caroline

Threshold for defining PSMA-positivity prior to 177Lu-PSMA therapy: a comparison of [68Ga]Ga-PSMA-11 and [18F]F-DCFPyL in metastatic prostate cancer

2023 . Heilinger, Jan | Weindler, Jasmin | Roth, Katrin Sabine | Krapf, Philipp | Schomäcker, Klaus | Dietlein, Markus | Drzezga, Alexander | Kobe, Carsten

Chronic Prurigo Including Prurigo Nodularis: New Insights and Treatments

2023 . Müller, Svenja | Zeidler, Claudia | Ständer, Sonja

The quality crisis of the pharmaceutical industry in India

2023 . Reddy T., Prashant | Thakur, Dinesh S. | Hattemer-Apostel, Rita

Treatment of Patients with Multiple Sclerosis Transitioning Between Relapsing and Progressive Disease

2023 . Dimitriou, Nikolaos G. | Meuth, Sven G. | Martinez-Lapiscina, Elena H. | Albrecht, Philipp | Menge, Til

Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy

2023 . Michaeli, Daniel Tobias | Michaeli, Christoph | Albers, Sebastian | Boch, Tobias | Michaeli, Julia Caroline

WHO informal consultation on regulatory considerations for evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases, 20-22 April 2021

2022 . Liu, Margaret A. | Zhou, Tiequn | Sheets, Rebecca L. | Meyer, Heidi | Knezevic, Ivana

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