Despite advances in pharmacovigilance, numerous deficiencies have been identified; postmarketing surveillance remains the weakest link in the regulatory process. Regulatory authorities have tended ...

Nov. 6, 2024 – The FDA has updated the labels for all GLP-1 weight loss drugs with a warning about pulmonary aspiration ...

The warning affects all treatments containing GLP-1 receptor agonists, including semaglutide ( Ozempic, Wegovy, Rybelsus ), ...

Recently the U.S. Food and Drug Administration (FDA) issued updated safety warnings for all glucagon-like peptide 1 receptor ...

Nevertheless, these findings could have prompted the FDA to mandate a postmarketing clinical trial designed to specifically assess the cardiovascular risks associated with rofecoxib use.

In addition, the postmarketing registry only listed adverse events that occurred during the time of treatment or shortly thereafter. As a consequence, no information was provided on the occurrence ...

Qsymia’s manufacturer also released postmarketing data showing the oral therapy for weight loss was associated with ...

In October 1999, the Office of Postmarketing Drug Risk Assessment, created the previous year, took over the review of proposed proprietary drug names. After a drug has passed through IND ...

Postmarketing requirement fulfilled based on data demonstrating QYSMIA® reduces blood pressure -CAMPBELL, Calif., Oct. 28, 2024 (GLOBE ...

“There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep ...

The FDA has updated the labels for all GLP-1 receptor agonists, including popular medications Ozempic, Wegovy, Saxenda and Mounjaro, to include a new warning about the risk of pulmonary aspiration ...