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Archive for the ‘Medication Guides’ Category

Still No Discussion of Packaging

Thursday, October 21st, 2010

Today I came across two different stories on the emerging roles that pharmacists are playing in medication therapy management. We received a press release from the National Association of Chain Drug Stores (NACDS) on its participation in the U.S. Senate Health Fair last week in Washington, DC, and later on ...

Pharmacy Group Pushes One-Document Solution, But What Does FDA Think?

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 ...

FDA Asks Drug Maker to Monitor ESA Prescribing

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). ...

Could MTM Be the Key to Healthcare Reform?

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 ...

Could More Medication Guides and Package Inserts Be on FDA’s Wish List?

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FDA has issued draft guidance for industry on Risk Evaluation and Mitigation Strategies (REMS), which are required for certain drugs or biologics.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 ...