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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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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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AstraZeneca breathes sigh of relief as court blocks US Symbicort generic

pharmaphorum

Symbicort was first FDA-approved in 2006 as a treatment for asthma, followed by an extension to its label covering COPD in 2009. In September last year Mylan and Kindeva argued in the trial that each asserted patent claim is invalid under US patent laws.

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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.

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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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OTC antiemetic medications: Relief for nausea and vomiting

The Checkup by Singlecare

Be sure to follow the dosing instructions on the label for your child’s age. Antiemetic side effects Most OTC antiemetics are well-tolerated and safe if taken according to the labeled instructions. Dramamine is safe for pregnant women to take and may also be used for postoperative nausea after surgery.

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