16 DecemberICH E14 and S7B: A Note From the SPS President Dear Members of SPS, Since the link between serious ventricular arrhythmias among patients taking e... read more
25 NovemberICH E14/S7B Q&As: Public Comment Closes Soon! As a safety pharmacology leader, your voice matters! The ICH E14/S7B Q&As are still open for co... read more
20 OctoberCongratulations 2021 Incoming Board Members!We look forward to fulfilling the SPS Mission alongside you in 2021 and beyond. Vice Presiden... read more
18 JanuaryMetformin use reduces risk of death for patients with COVID-19 and diabetesUse of the diabetes drug metformin - before a diagnosis of COVID-19 - is associated with a threefold... read more
15 JanuaryFDA VoicesInsights into the agency's work in the areas of medical products, food, tobacco, policy, consumer sa... read more
15 JanuaryFDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomasOn January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhe... read more
15 JanuaryUser Fee ListsFiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016.... read more
15 JanuaryWhat's New Related to DrugsWant to know what's new on drugs from FDA? This page provides quick links to the latest on a variety... read more
15 JanuaryNon-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic ActSection 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to ... read more
