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Regulatory Affairs News and topics related to marketing laws, regulations and guidelines. Includes news feeds from FDA, including press releases, advisory committee meeting announcements, and drug safety notices.

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  #1  
Old 5th July 2011, 03:30 PM
FDA Reporter FDA Reporter is offline
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Default Pharma Companies Petition FDA to Establish Binding Regulations Re Off-Label Communs

Earlier today, Lilly joined six other companies (Allergan, Johnson & Johnson, Novartis, Pfizer, Novo, and Sanofi-Aventis) in filing a “citizen petition” with the U.S. Food and Drug Administration. The purpose: to seek clarification on the agency’s policies about communicating truthful, non-misleading scientific information that is not included in product labeling.

In particular, the petitioners are looking for more guidance in four key areas: scientific exchange, sharing information with formulary committees and payers, providing independent third-party clinical practice guidelines, and responding to unsolicited requests for information.

More info...

See petition attached (pdf).
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File Type: pdf CitizensPet_FDA_July_5_2011.pdf (1.08 MB, 527 views)
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Old 16th January 2012, 10:13 PM
online_doctor online_doctor is offline
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Default I guess working together with the regulatory

I guess working together with the regulatory bodies will help any company stay within legal waters when marketing or packaging their products and keep their consumers properly and adequately informed of the contents. My doctor always warned me of misguiding labels, and I hope we will see less of that in the future!
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Old 30th January 2012, 01:00 AM
liger123 liger123 is offline
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Originally Posted by online_doctor View Post
I guess working together with the regulatory bodies will help any company stay within legal waters when marketing or packaging their products and keep their consumers properly and adequately informed of the contents. My doctor always warned me of misguiding labels, and I hope we will see less of that in the future!
Agree with you. The pharmaceutical industry is riddled with inaccuracies and inefficiencies due to rogue departments and sites. The regulatory bodies have their task cut out especially when it comes to moderating unapproved online clinics and setting up a publicly viewable Govt regulated erectile dysfunction clinics list.

Last edited by liger123 : 30th January 2012 at 01:17 AM.
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