Results 151 to 160 of about 6,029 (168)

FDA Approval Summary: Lisocabtagene Maraleucel for Relapsed or Refractory Follicular Lymphoma. [PDF]

Clin Cancer Res
Britton K, Mahat U, Richardson NC, Tegenge M, Gao Q, Theoret MR, Fashoyin-Aje LA.   +6 more
europepmc   +1 more source

A multicenter, postmarketing surveillance of elobixibat in patients with chronic constipation in Japan: A final analysis report. [PDF]

SAGE Open Med
Nakajima A, Umeyama M, Higashikawa M, Shimada Y, Arai Y.   +4 more
europepmc   +1 more source

Dose Optimization in Oncology Drug Development: Risk Factors for Postmarketing Requirements and Commitments. [PDF]

Clin Pharmacol Ther
Kitagaki H, Takeda K, Murai K, Maeda H.
europepmc   +1 more source

Dose Determinations at Drug Approval Reviews: FDA-Approved Drugs in Past 5 Years. [PDF]

Clin Pharmacol Ther
Mita S, Ono S.
europepmc   +1 more source

Regulatory Impact of Selected U.S. FDA Postmarketing Safety Registries Conducted for Drugs Used to Treat Inflammatory or Autoimmune Conditions. [PDF]

Pharmacoepidemiol Drug Saf
Guiriansoro Z, Oussova T, Weissfeld J.
europepmc   +1 more source

Pharmacovigilance analysis of FcRn antagonists in the treatment of myasthenia gravis: A disproportionality analysis based on the FAERS database. [PDF]

Hum Vaccin Immunother
Liu B, Zhang W, Chen Y, Han A, Chen D.
europepmc   +1 more source

A 20-year FAERS analysis of hypersensitivity reports to chlorhexidine and povidone-iodine (2004-2024). [PDF]

J Allergy Clin Immunol Glob
Jagadish I, Estrada-Mendizabal RJ, Gonzalez-Estrada A, Volcheck GW, Rukasin CRF.   +4 more
europepmc   +1 more source

Patient-Reported Outcomes of Rotigotine in Parkinson's Disease: Real-World Evidence on Symptom Control and Quality of Life From China. [PDF]

Parkinsons Dis
Zhu X, Zhu H, Chen L, Heidbrede T, Shimizu S, Zhou Y, Sun W, Cheng W, Cui G, Wang J.   +9 more
europepmc   +1 more source

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Active Surveillance of Postmarket Medical Product Safety in the Federal Partners' Collaboration

Medical Care, 2012
After half a century of monitoring voluntary reports of medical product adverse events, the Food and Drug Administration (FDA) has launched a long-term project to build an adverse events monitoring system, the Sentinel System, which can access and evaluate electronic health care data to help monitor the safety of regulated medical products once they ...
Melissa A, Robb, Judith A, Racoosin, Chris, Worrall, Summer, Chapman, Trinka, Coster, Francesca E, Cunningham   +5 more
openaire   +2 more sources