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From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

The FDA Law Blog

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP).

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10 foods high in vitamin D

The Checkup by Singlecare

Department of Agriculture (USDA) requires it to be labeled “farmed” or” wild-caught.” Check the nutrition facts label to find the amount of vitamin D and other nutrients contained in individual products. The nutritional fact label will identify the recommended daily value of vitamin D suggested for the average adult.

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Case Study 5 – Regulatory Affairs Strategy and Project Team Lead

Impact Pharmaceutical Services

IMPACT (now part of Syner-G BioPharma Group) has been providing Regulatory Affairs support to a mid-size pharmaceutical company since 2009. Regulatory Affairs Strategy and Project Team Lead. Even though this company has a Regulatory Affairs Department, their rapid growth over the years has made “in-sourcing” of help a necessity.

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Can a nasal spray tackle agitation in autism?

Pharmaceutical Technology

Off-label medication options. Abilify (aripiprazole) , marketed by Bristol Myers Squibb and Otsuka Pharmaceuticals, was approved in 2009 for irritability treatment in six to 17-year-old children with ASD. An inability to clearly communicate with others and express their wants and needs results in frustration, he adds.

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Can you use metronidazole for cats?

The Checkup by Singlecare

Although not FDA-approved for animals, metronidazole is used off-label in cats when prescribed in veterinary medicine. It diffuses into the offending microorganism, disrupting cell growth and division and eventually causing cell death of the microorganism.

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What was the most popular prescription in each state in 2023?

The Checkup by Singlecare

And it is sometimes used off-label for conditions like anxiety and insomnia—which affect 31% and 20% of Americans, respectively. It may also be used to treat restless legs syndrome, a condition causing an uncontrollable urge to move the legs, especially at night. Approximately 1.2% of the population in the United States has epilepsy.

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

Draft Report on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC. analysis (Source: L.E.K) Internet] 2023. cited 2023Dec] Available from: [link] European Parliament.