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.
- VPRIV. // Formulary;Apr2010, Vol. 45 Issue 4, p113
The article reports that the U.S. Food & Drug Administration (FDA) approved the enzyme replacement medication velaglucerase alpha (VPRIV), used for long-term treatment in patients with type one Gaucher disease. VPRIV is administered as an injection and the most common adverse effects include...
- Once-a-month injection approved to treat three types of arthritis. Thompson, Cheryl A. // American Journal of Health-System Pharmacy;6/1/2009, Vol. 66 Issue 11, p968
The article discusses the approval of the Simponi or golimunab injection by the U.S. Food & Drug Administration and Centocor Ortho Biotech Inc. The injection is a once-monthly treatment for three types of arthritis. The article lists the common side effects of the medication which may include...
- 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...