Regulatory Roundup: FDA Introduces Safe Use Initiative, More...

November 12, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Commissioner Hamburg addresses the nation's doctors in a letter about the influzenza A (H1N1) virus and vaccine.

The US Food and Drug Administration introduced the Safe Use Initiative, a program designed to reduce the likelihood of preventable harm from medication use. The agency said in a press release that millions of people are harmed every year from inappropriate medication use, and that many injuries occur as a result of incomplete access to information about a drug, patient, or patient’s condition. FDA intends to collaborate with healthcare professionals and other stakeholders to identify drugs and drug classes that are linked to preventable harm.The agency also made public new draft guidance titled Dosage Delivery Devices for OTC Liquid Drug Products for companies that manufacture, market, or distribute over-the-counter liquid medications packaged with dosage-delivery devices such as calibrated cups, droppers, syringes, and spoons.

FDA Comissioner Margaret Hamburg sent a letter on Nov. 10, 2009, to America’s healthcare professionals that acknowledged their efforts during the 2009 influenza A (H1N1) outbreak and provided information on the safety of the H1N1 vaccines. The letter offered information designed to aid physicians in their discussions with patients about the manufacture, monitoring, and safety of the vaccine.

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