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Posts Tagged ‘FDA

Pharma and SM: one minute it’s on,…

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the next it’s off.

Old familiar worries” are “about adverse event and off-label discussions compounded by the delay of FDA guidelines”.

companies that abandon Facebook will miss out on a “powerful community that is already woven into billions of lives whose voices want and need to be heard“.

Business cases:

  • Sanofi’s VOICES Facebook page
  • Bayer’s tweets mistakes
  • Roche SM guideline
  • J&J Children with diabetes community
  • AstraZeneca Twitter discussion
Read more on:
Houston, Peter. Pharma and social media: time to become better friends. Pharmaceutical Executive, Digital edition, September 2011. pp.68-72
http://digital.findpharma.com/nxtbooks/advanstar/pe_201109/#/72
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Written by hbasset

October 6, 2011 at 7:38 pm

FDA not to plan social media guidance in 2011?!

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According John Mack, the Pharmaguy, the FDA “2011 Guidance Agenda doesn’t even include social media guidance.

I don’t think the FDA is being very transparent and is sending the industry conflicting signals.”

http://bit.ly/kl3BDE

Written by hbasset

June 1, 2011 at 5:08 pm

FDA announces Delay in Social Media Guidance

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According the InjuryBoard blog, FDA “has once again postponed the launch of its first draft guidance for social media. This marks the second delay announced on this project in the last four months“.

The FDA was supposed to release the guidelines in late December, but stated at the time that it would delay the release of the first draft guidance until the first quarter of 2011. That has been delayed again.

Emison, Brett. FDA Once Again Delays Guidance on Social Media. Injury Board Blog, Posted on April 05, 2011.

http://kansascity.injuryboard.com/fda-and-prescription-drugs/fda-once-again-delays-guidance-on-social-media.aspx?googleid=289696

Written by hbasset

April 6, 2011 at 10:32 am

SM & Pharmas: the industry awaits FDA guidance

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  Consumers increasingly are tapping the Internet and social media sites for health-related information. A recent survey conducted by the Pew Internet Project and the California HealthCare Foundation, which publishes iHealthBeat, found that 80% of Internet users look up medical-related information online. (…)

While online, consumers are likely to view promotions for health care products, but there currently are no federally imposed rules of the road governing pharmaceutical marketing activities (…)

FDA says the earliest it will take action is the first quarter of 2011
 

FDA is studying guidelines on several fronts, including:

  • How companies can respond to unsolicited consumer requests;
  • How companies can comply with regulations in the face of space constraints on sites like Facebook and Twitter;
  • How companies can fulfill post-marketing submission requirements;
  • What type of communications manufacturers or distributors are accountable for;
  • Using links on the Internet; and
  • How to correct misinformation.

 

(…) the industry has to find a harmony between offering information to consumers and health care professionals and making sure that that information is not misleading. In the “best interest of public health,” FDA is urgingthe regulated industry to ensure their product promotion is accurate, balanced and non-misleading regardless of the medium.

The opportunities to disseminate and share information across a global, online enterprise are almost incalculable, as is the amount of data at the fingertips of anyone with an Internet connection or smart phone. It remains to be seen how product marketing will co-exist alongside FDA scrutiny and just how detailed FDA guidelines will be.

 Pogachar, Mickael. Questions Linger on Social Media Regulations for Pharma. iHealthBeat, Tuesday, March 01, 2011
http://www.ihealthbeat.org/features/2011/questions-linger-on-social-media-regulations-for-pharma.aspx

Written by hbasset

March 3, 2011 at 8:25 pm

Drugs.com: deal with FDA

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www.drugs.com is one of the rare free services in the biomedical area which competes with paid services.

The web site offers extensive Drugs sheet, including pharmacokinetics (PK) and clinical data, links to free resources, anufacturing and marketing information (label, etc.), etc.

Drugs.com annoucnes a new deal with FDA to expand access to the FDA’s consumer health information. Drugs.com seeks to provide patients with information to better manage their own healthcare and to assist in the reduction of medication errors. It attracts more than 12 million unique visitors each month.

The service will feature soon FDA Consumer Update articles, videos, and slideshows. The partnership will also provide access to FDA health information on Drugs.com’s mobile phone platform.

Press news related by KnowledgeSpeak

Written by hbasset

May 27, 2010 at 6:58 pm

Posted in Pharmaceutical Industry

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