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

FDA Law Blog: Biosimilars

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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Teething

RX Note

Laboratory analysis of some homeopathic remedies found greater amounts of Atropa belladonna (deadly nightshade, an anticholinergic agent) than claimed on the label. . * UpToDate does not recommend OTC (including homeopathic remedies) or prescription-strength topical analgesics (e.g.,

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FDA Authorizes Copenhagen Classic Snuff to be Marketed as a Modified Risk Tobacco Product

LifeProNow

The MRTP process outlined in the 2009 Family Smoking Prevention and Tobacco Control Act allows companies to submit applications for the FDA to evaluate whether a tobacco product may be sold or distributed for use to reduce harm or the risk of tobacco-related disease.

Labelling 100
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Case Study 5 – Regulatory Affairs Strategy and Project Team Lead

Syner-G

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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FDA OPDP Look Back at 2021 – The Yawning Gap

Eye on FDA

Back in 2009 you may recall that FDA issued 45 Untitled Letters aimed at 14 companies regarding the use of banner ads/sponsored links where clearly benefits of a branded product were available, but risk information only ascertainable by clicking on a link. in November 2009. The Substance: What triggered the enforcement actions?

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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.