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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 […]
June 29, 2021

FDA Drug Safety Communication: FDA eliminates the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing diabetes medicines

The U.S. Food and Drug Administration (FDA) is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which are approved as […]
June 29, 2021

Novel Laboratories, Inc. d.b.a LUPIN – 613385 – 06/11/2021

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Ms. Vinita D. Gupta Recipient Title Group President-CEO Novel Laboratories, Inc. d.b.a LUPIN B/4 Laxmi TowersBandra Kurla […]
June 29, 2021

Flora Inc – 613310 – 06/07/2021

Delivery Method: Overnight Delivery Product: DrugsFood & Beverages Recipient: Recipient Name Thomas O. Greither Recipient Title President Flora Inc 805 E. Badger Rd.Lynden, WA 98264-9502United States […]
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