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SPS News

16 December

ICH 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 November

ICH 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

3 November

Webinar of Interest! An Update on COVID-19: Basic and Clinical Perspectives

... read more

20 October

Congratulations 2021 Incoming Board Members!

We look forward to fulfilling the SPS Mission alongside you in 2021 and beyond.   Vice Presiden... read more

Scientific News

18 January

Metformin use reduces risk of death for patients with COVID-19 and diabetes

Use of the diabetes drug metformin - before a diagnosis of COVID-19 - is associated with a threefold... read more

15 January

FDA Voices

Insights into the agency's work in the areas of medical products, food, tobacco, policy, consumer sa... read more

15 January

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas

On January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhe... read more

15 January

User Fee Lists

Fiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016.... read more

15 January

What's New Related to Drugs

Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety... read more

15 January

Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act

Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to ... read more

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