Results 161 to 170 of about 19,507 (228)

Anticancer Drug Approval in China: From Acceleration of Access to Certainty of Benefits. [PDF]

Health Data Sci
Zhang J.
europepmc   +1 more source

Career pathways for pharmacologists in India: A clinical pharmacologist's perspective.

Indian J Pharmacol
Singh S, Tiwari K.
europepmc   +1 more source

Safety and effectiveness of selpercatinib in patients with RET fusion-positive non-small cell lung cancer in real-world clinical practice: a postmarketing study in Japan. [PDF]

Jpn J Clin Oncol
Chen Y, Mori J, Wakabayashi S, Urayama KY.   +3 more
europepmc   +1 more source

Pragmatic implementation of intravascular lithotripsy in Japan based on the guidelines for proper use. [PDF]

Cardiovasc Interv Ther
Shiba T, Nakamura M, Kozuma K, Sugano T, Aizawa K, Yabana N, Ishii K.   +6 more
europepmc   +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]

BMJ Oncol
Kurian M, Ferrell WJ, Ulloa Perez E, Hubbard R, Joffe S, Mamtani R, Parikh RB, Lynch HF.   +7 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]

Hemasphere
Ghia P, Bajwa N, Corry AJ, Jannuru S, Kreuzbauer G, Pareek M.   +5 more
europepmc   +1 more source

Flexibility over rigor: stakeholder acceptance of the limitations of confirmatory studies following accelerated approval. [PDF]

Health Aff Sch
Fernandez Lynch H, Lee S, Herder M, Ross JS, Ramachandran R.   +4 more
europepmc   +1 more source

Real-world safety and effectiveness of alemtuzumab for relapsed or refractory chronic lymphocytic leukaemia: results from postmarketing surveillance in Japan. [PDF]

Jpn J Clin Oncol
Sasakura Y, Hatanaka M, Ishizawa K.
europepmc   +1 more source

Safety and Performance of Postmarketing Breast Implants: An Integrated Review with Technovigilance Data. [PDF]

J Clin Med
Ramalho AAL, Tavares AA, da Silva HN, Navarro RF, da Silva VAVC, Melchior SC, Vicente MG, Fook MVL, Silva SML.   +8 more
europepmc   +1 more source

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Postmarketing surveillance for drug abuse

Drug and Alcohol Dependence, 2003
Assessing actual abuse of prescribed medications requires postmarketing surveillance. In this article we discuss general systems of postmarketing surveillance that exist as of the end of 2002 in the United States and two medication-specific surveillance systems that were devised and tested.
Cynthia L Arfken
exaly   +3 more sources