Results 11 to 20 of about 10,049 (144)

Adverse Reactions Identified after Approval of Novel Medicines: Analysis of 339 New Molecular Entities and Therapeutic Biologics. [PDF]

Clin Pharmacol Ther
Postmarketing safety surveillance data identify safety issues not identified in preapproval clinical trials. We describe the frequency of new safety issues overall and by labeling section and the relationship of the most commonly added safety issues with the cumulative number of prescriptions dispensed via retail pharmacies.
Pinnow E, Day B, Zhou EH, Woods C, Dwumfour N, Lee JY, Bulatao I, Cherkaoui S, Kalaria M, Brajovic S, Sadiq N, Sistani F, Lee M, Chai G, Dal Pan G.   +14 more
europepmc   +2 more sources

Analysis of Suffix Use for Biosimilar Product Identification in Postmarketing Adverse Event Reporting. [PDF]

Clin Pharmacol Ther
Accurate identification of medicines used in adverse event reports is crucial for effective postmarketing safety surveillance. The US Food and Drug Administration's (FDA) four‐letter suffix naming convention was designed to facilitate accurate biological product identification, but the extent to which these suffixes have been incorporated into ...
Stojanovic D, Wolf L, Ricci MS, Muñoz MA.   +3 more
europepmc   +2 more sources

Drug Safety Monitoring Information

Безопасность и риск фармакотерапии, 2021
Analysis of administrative decisions of foreign regulatory authorities on the recall of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profile, conducted by experts of the Scientific Centre for ...
E. V. Shubnikova, E. O. Zhuravleva, N. Yu. Velts, P. M. Giulakhmedova, A. A. Druzhinina   +4 more
doaj   +1 more source

Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non‐orphan drugs approved by the FDA

Clinical and Translational Science, 2022
Clinical pharmacology is an integral discipline supporting the development, regulatory evaluation, and clinical use of drugs for the treatment of both common and rare diseases.
Julie Hsieh, Martina Sahre, Xinning Yang, Rajanikanth Madabushi, Anuradha Ramamoorthy   +4 more
doaj   +1 more source

Monitoring Drug Safety Information - Recommendations of Foreign Regulatory Authorities

Безопасность и риск фармакотерапии, 2020
Analysis of administrative decisions of foreign regulatory authorities on the recoil of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profi le, conducted by experts of the Scientifi c Centre ...
Elena V. Shubnikova, Marya A. Darmostukova, Irina I. Snegireva, Evgeniya O. Zhuravleva   +3 more
doaj   +1 more source

Uncovering Knowledge Gaps in the Safety Profile of Antiangiogenic Drugs in Cancer Patients: Insights from Spontaneous Reporting Systems Studies

Pharmaceuticals, 2023
Global repositories of postmarketing safety reports improve understanding of real-life drug toxicities, often not observed in clinical trials. The aim of this scoping review was to map the evidence from spontaneous reporting systems studies (SRSs) of ...
Valerio Ciccone, Marina Ziche, Andrea Spini, Sandra Donnini   +3 more
doaj   +1 more source

First‐Line Osimertinib in Patients with EGFR‐Mutant Advanced Non‐Small Cell Lung Cancer: Outcome and Safety in the Real World: FLOWER Study

The Oncologist, EarlyView., 2021
Abstract Lessons Learned Osimertinib has confirmed effectiveness in this real‐world population of patients with EGFR‐mutant advanced non‐small cell lung cancer. Thromboembolic events occur more frequently than previously reported, suggesting a thrombotic diathesis that requires further investigation. Patients with at least three metastatic sites, brain
Martina Lorenzi, Alessandra Ferro, Fabiana Cecere, Daniela Scattolin, Alessandro Del Conte, Alessandro Follador, Sara Pilotto, Valentina Polo, Mariacarmela Santarpia, Rita Chiari, Alberto Pavan, Alessandro Dal Maso, Valentina Da Ros, Giada Targato, Sabrina Vari, Stefano Indraccolo, Fiorella Calabrese, Stefano Frega, Laura Bonanno, Pier Franco Conte, Valentina Guarneri, Giulia Pasello   +21 more
wiley   +1 more source

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

BMC Medicine, 2019
Background Postmarketing commitments are clinical studies that pharmaceutical companies agree to conduct at the time of FDA approval, but which are not required by statute or regulation.
Joshua D. Wallach, Anita T. Luxkaranayagam, Sanket S. Dhruva, Jennifer E. Miller, Joseph S. Ross   +4 more
doaj   +1 more source

Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval

Clinical and Translational Science, 2021
For drugs that are intended to fill unmet medical needs, such as the treatment of rare diseases or a subtype of cancer, it can take a long time to conduct confirmatory clinical trials due to limited patient availability.
Shunsuke Matsushita, Keisuke Tachibana, Tetsuya Kusakabe, Ryuichi Hirayama, Yasuo Tsutsumi, Masuo Kondoh   +5 more
doaj   +1 more source

Real-world effectiveness and safety of glecaprevir/pibrentasvir therapy in patients with chronic hepatitis C virus infection in Switzerland

Swiss Medical Weekly, 2021
AIM OF THE STUDY In the era of pangenotypic treatment regimens against hepatitis C virus (HCV) infection, data from postmarketing observational studies are crucial to better understand the treatment patterns used in specific countries and ...
Beat Müllhaupt, David Semela, Lisa Ruckstuhl, Lorenzo Magenta, Olivier Clerc, Ralph Torgler, Francesco Negro, Nasser Semmo   +7 more
doaj   +1 more source