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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 […]
June 29, 2021

JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health – 612754 – 05/26/2021

Delivery Method: United Parcel Service Product: DrugsFood & Beverages Recipient: Recipient Name Jeffrey Neil Burgee Recipient Title CEO JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health […]
June 28, 2021

FDA Drug Safety Communication: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData SummaryReferences   Safety Announcement [6-30-2011] The U.S. Food and Drug Administration (FDA) is informing the public that […]
June 25, 2021

Las terapias más antiguas no son necesariamente mejores para el reemplazo de la hormona tiroidea

Image English Millones de personas tienen glándulas tiroideas que no producen suficiente hormona tiroidea para satisfacer las necesidades de su cuerpo. El hipotiroidismo, también llamado tiroides […]
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