Growth of REMS challenges FDA, stakeholders
- OVERVIEW OF RISK EVALUATION AND MITIGATION SYSTEMS (REMS). // Davis's Drug Guide for Nurses, 12th Edition;2011, p22
The article focuses on the risk evaluation and mitigation systems (REMS) used by the U.S. Food and Drug Administration (FDA) for the detection, evaluation, prevention and mitigation of drug adverse events. It states that the agency can require the use of REMS either as part of the drug approval...
- Advisory panel votes against Qnexa. // OB/GYN Clinical Alert;Sep2010 Pharmacology, p2
The article discusses the disapproval of the weight-loss drug Qnexa by the U.S. Food and Drug Administration (FDA) due to its side effects such as depression, sleep disorders, and other cognitive disorders.
- MuckReads Podcast: When Diet Drugs Harm Instead of Help. Bronzan, Nicole Collins // Pro Publica;Apr2015, p1
The article introduces a podcast on an investigative report which found that in the last three years, the U.S. Food and Drug Administration (FDA) has approved five new drugs on the market that are potentially harmful.
- REMS, Patient Safety, and Professional Liability Risks. Heagerty, Kathryn E. // Innovations in Clinical Neuroscience;Mar2012, Vol. 9 Issue 3, p27
The article provides an answer to a question of what Risk Evaluation and Mitigation Strategy (REMS) is and the reasons as to why it is so important.
- Curing what ails you. Montville, Leigh // Golf World;4/25/2008, Vol. 61 Issue 35, p24
The article offers information on Par-Ex pill which is underway for the approval from the U.S. Food and Drug Administration (FDA). The pill should by taken once a day and be taken after the morning meal to increase distance on drives an average of 130 yards. The drug is predicted to become the...
- Serious Adverse Drug Effects – Seeing the Trees through the Forest. Gurwitz, Jerry H. // New England Journal of Medicine;3/30/2006, Vol. 354 Issue 13, p1413
The article focuses on the author's views on issues related to side effects of drugs. The author cites a recent study by researcher L.K. Park-Wyllie, which discusses side effects of some of the widely prescribed medications, including gatifloxacin. The author refers to a report released by the...
- Finding New Treatments for Diabetes – How Many, How Fast .Â .Â . How Good? Nathan, David M. // New England Journal of Medicine;2/1/2007, Vol. 356 Issue 5, p437
The author ponders on the development of treatments for diabetes. He comments on the slow development of medications for such illness, and offers his views on how the U.S. Food and Drug Administration approves these medications. He comments that newer classes of antidiabetes medications do not...
- FDA APPROVES LAMOTRIGINE ORALLY DISINTEGRMING TABLETS FOR BIPOLAR I DISORDER. Naccari, Christopher // Primary Psychiatry;Jun2009, Vol. 16 Issue 6, p12
The article reports on the approval of lamotrigine orally disintegrating tablets (ODT) for the treatment of bipolar I disorder in patients above 18 years of age by the U.S. Food and Drug Administration (FDA). The tablet is suitable for patients who have difficulty swallowing medication as it...
- The Rosiglitazone Story ï¿½ Lessons from an FDA Advisory Committee Meeting. Rosen, Clifford J. // New England Journal of Medicine;8/30/2007, Vol. 357 Issue 9, p844
This editorial comments on the lessons learned by a U.S. Food & Drug Administration (FDA) advisory committee while investigating the heart risks associated with the use of rosiglitazone in patients with type 2 diabetes. The author says three lessons were learned: the pathogenesis of the disease...