Pharmaceutical Digital Regulation
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Pharmaceutical Digital Regulation
An occasional page to collect a few links and stories relating to pharma digital regulation. The codes, laws, policies, guidance, cases... you know, the exciting stuff.
Curated by Felix Jackson
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Pharmaceutical companies 'should establish Social Media policy'

Pharmaceutical companies 'should establish Social Media policy' | Pharmaceutical Digital Regulation | Scoop.it

Pharmaceutical companies should establish a corporate social media policy, attorney John Manthei, with Latham & Watkins LLP in Washington, said Sept. 17.

 

Speaking during a session on drug product compliance at the Food and Drug Law Institute's Advertising & Promotion Conference, Manthei said the Food and Drug Administration is “incredibly” advanced at using social media, but it hasn't yet said how it will regulate others when it comes to social media.

Manthei said the FDA is required by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) to issue specific guidance on social media by July 9, 2014. However, he said FDA's message in warning letters has been that “current standards apply” when it comes to social media.

Social media is “interactive and the formats are constantly evolving,” Manthei said.

Felix Jackson's insight:

Specific considerations for social media:

• “clear corporate social media policy and provide adequate training to employees.”

• “if you plan to allow third-party content on company-hosted media, ensure [that] you maintain control to maintain compliance.”

• Have a clear “terms of use” to alert users that content will be reviewed and may be deleted.

 

But the main considerations remain the big ones:

• partner with marketing team members to ensure risk presentations get equal time and attention in promotional materials during the drafting stage (including labeling);

• lean on medical reviewers to understand study designs and the limitations for supporting data;

• not overlook investigational product materials and websites;

• ensure product-related press releases undergo multidisciplinary review; and

• inventory claims supported by composite score data for overstatement of efficacy.

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Sven Awege's curator insight, September 20, 2013 3:25 AM

Didn't we know this already!

I guess communication is a lot to do with repetition.

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New FDA Law Paves Way For mHealth Regulations -- InformationWeek

New FDA Law Paves Way For mHealth Regulations -- InformationWeek | Pharmaceutical Digital Regulation | Scoop.it
By letting FDA proceed with developing regulations for mobile health apps, Congress assures mHealth industry that clarity is on the horizon.
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Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications

CDRH CBER...
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Stricter device regulation needed—lessons from the past : The Lancet

On June 18, the UK's Department of Health published its final expert report on the safety of Poly Implant Prostheses (PIP) breast implants, which reviewed evidence about the 240 000 implants of this type that have been used in England.
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This INSANE Graphic Shows How Ludicrously Complicated Social Media Marketing Is Now

This INSANE Graphic Shows How Ludicrously Complicated Social Media Marketing Is Now | Pharmaceutical Digital Regulation | Scoop.it

How are we expected to regulate this?

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In a nutshell: the FDA draft guidance about responding to requests for off-label information | medDigital

In a nutshell: the FDA draft guidance about responding to requests for off-label information | medDigital | Pharmaceutical Digital Regulation | Scoop.it

Blog by Sally and Felix summarizing the guidance.

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Translating the New FDA Social Media Guidance

Translating the New FDA Social Media Guidance | Pharmaceutical Digital Regulation | Scoop.it
The FDA has released some guidance for using one aspect of social media. We created a handy flow chart that dissects all the requirements.
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Should pharmaceutical companies now register their own apps as medical devices? | pharmaphorum

This is an article about medical apps and offers considerations when developing an app and questions when apps can be classed as medical devices and therefore fall under the appropriate medical device regulations.
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Mobile Medical Applications

The FDA has a public health responsibility to oversee the safety and effectiveness of a small subset of mobile medical applications that present a potential risk to patients if they do not work as intended.
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Shocking. Chinese woman sentenced to one year in labour camp for one retweet

Shocking. Chinese woman sentenced to one year in labour camp for one retweet | Pharmaceutical Digital Regulation | Scoop.it

It is amazing to see the different punishments in China and UK for inappropriate use of social media. Clearly driven by the political differences, but it reminds us how regulation differs across the world.

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