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FDA Pushes Rule on Labeling by Generics to Next Year
With an aim to create parity between brand-name and generic drugs, the FDA was expected to pass a rule next month that would allow generic manufacturers to independently provide safety updates on their labels. The decision has now been pushed back by 9 months.
A controversial new rule for updating generic drug labeling that the FDA was expected to finalize next month will not be published until the fall of 2015, an agency spokeswoman says.
The rule, which the FDA proposed last year, would allow generic drug makers to independently update safety warnings, something that only brand-name drug makers can currently do before receiving FDA permission.
The agency proposed the rule in response to a 2011 U.S. Supreme Court decision that federal law does not permit generic drug makers to make such changes independently and, therefore, they should not be held accountable for a failure to warn against a risk.
The court ruling sparked an outcry that generic labeling would be insufficient to warn patients about the risks associated with numerous medications, especially at a time when 86% of all prescriptions filled are for generic drugs, according to the IMS Institute for Healthcare Informatics.
Complete article on The Wall Street Journal : http://on.wsj.com/1vqiSe2
Standard Criteria for Loss of Ambulation Needed in DMD
April 19th 2024A recent study suggests the differences between ambulation definitions for patients with Duchenne muscular dystrophy (DMD) can impact the identification of ambulant vs nonambulant individuals, and standard criteria across settings are needed.
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Overcoming Employment Barriers for Lasting Social Impact: Freedom House 2.0 and Pathways to Work
April 16th 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. Welcome to our second episode, in which we learn all about Freedom House 2.0 and the Pathways to Work program.
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Early Involvement Critical in Treating Immunotherapy-Induced Overlap Syndrome
April 19th 2024A series of case studies reveals the importance of early diagnosis and involvement of special teams of clinicians when dealing with potential cases of overlap syndrome, which encompasses myocarditis, myasthenia gravis, and immune checkpoint inhibitor–related myositis.
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Making Giant Strides in Maternity Health Through Baby Steps
April 9th 2024To help celebrate and recognize National Minority Health Month, we are kicking off a special month-long podcast series with our strategic alliance partner, UPMC Health Plan. Welcome to our first episode, which is all about the Baby Steps Maternity Program and its mission to support women throughout every step of their pregnancy journey.
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