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July 1, 2021

FDA Drug Safety Communication: Safety Review update of Abacavir and possible increased risk of heart attack

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [03-01-2011] The U.S. Food and Drug Administration (FDA) is updating the public about […]
June 30, 2021

Public Notification: 365 SKINNY High Intensity contains hidden drug ingredient

[6-30-2021] The Food and Drug Administration is advising consumers not to purchase or use 365 SKINNY High Intensity, a product promoted and sold for weight loss […]
June 30, 2021

Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies – 06/30/2021 – 06/30/2021

On This Page Date: June 30, 2021 Time: 12:00 PM – 1:00 PM ET [embedded content] Visit CDER Small Business and Industry Assistance Safety Reporting Requirements […]
June 29, 2021

Coronavirus (COVID-19) Update: June 29, 2021

For Immediate Release: June 29, 2021 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: The […]
June 29, 2021

FDA Drug Safety Communication: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse

[ 06-07-2016 ] The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea […]
June 29, 2021

FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes

The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack […]
June 29, 2021

Clinical Investigator Inspection List (CLIIL)

The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new […]
June 29, 2021

FDA Drug Safety Communication: FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients

In an effort to reduce the serious risk of infection spread through sharing of multi-dose diabetes pen devices intended for single patient use only, the U.S. […]
June 29, 2021

Assessment of the Use of Patient Experience Data in Regulatory Decision-Making

Section 3004 of the 21st Century Cures Act directs FDA to report on the use of patient experience data in regulatory decision-making, especially focusing on the […]
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