Archive for the ‘Medication Guides’ Category
Wednesday, August 11th, 2010
Almost a year ago, FDA held the workshop, "Providing Effective Information to Consumers about Prescription Drug Risks and Benefits," to explore whether “one document” could be developed for dispensing consistent information with all prescription drugs. The workshop brought to light the scant information that patients are often provided as well ...
Posted in FDA, Labeling, Medication Guides, Package Inserts, Pharmacies | 2 Comments »
Tuesday, February 16th, 2010
I have always heard that historically, FDA has pretty much just regulated the manufacture and marketing of the products it oversees (i.e., pharmaceuticals and medical devices, among others) but not the practice of medicine itself. Currently, though, FDA can mandate certain activities under a risk evaluation and mitigation strategy (REMS). ...
Posted in FDA, Hospital, Labeling, Medication Guides, REMS, Safety | No Comments »
Thursday, January 21st, 2010
The National Association of Chain Drug Stores (NACDS) says that pharmacists play an important role in improving patient outcomes and saving healthcare costs. Could they help reform healthcare ahead of (or instead of) any legislation? Can you help them?
NACDS cites the briefing paper Medication Therapy Management: Catching Errors, Saving ...
Posted in Medical Errors, Medication Guides, Medication Therapy Management, Package Inserts, Safety | No Comments »
Wednesday, September 30th, 2009
FDA has issued draft guidance for industry on Risk Evaluation and Mitigation Strategies (REMS), which are required for certain drugs or biologics. Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA gained authority to require the submission and implementation of a REMS if the agency decides a ...
Posted in Medication Guides, Package Inserts, Safety | No Comments »
