Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Patient Participation in Medical Product Discussions: Comments Submitted to Docket

Patient Participation in Medical Product Discussions: Comments Submitted to Docket | Pharmaguy's Insights Into Drug Industry News | Scoop.it
 
  • Please see the comments of Hunter Syndrome Research Coalition and member organization Saving Case & Friends, Inc. in the attached PDF.


  • I am commenting about the impact FDA decisions make to me as a patient with type 1 diabetes and a provider of diabetes care. I am concerned about the wide range in glucose...


 
  • We thank you for the opportunity to submit these comments in response to Federal Register Notice FDA-2014-N-1698, FDA Activities for Patient Participation in Medical Product...

  • Involvement of the patient community in drug development is a worthy goal. I co-organized a Washington conference in 2013 called "Selling Sickness: People before profits" with the...

  • Dear FDA panel members, I come from the viewpoint of a Physician Assistant specializing in 11 of 14 years in OB/GYN with surgical experience. I have a very clear understanding of...

  • First off, I want to give FDA a BIG THANKS for its openness with the Diabetes Community in 2014. FDA opened a number of dockets for people with diabetes to comment on and we...

  • I attended the meetings on Female Sexual Dysfunction (October 27/28) as an observer. I was surprised to see that the majority of patient voices and the loudest expert voices all...

  • The Even the Score campaign is just propaganda. Sprout cannot try to make the case that 43% of women have a sexual dysfunction (which includes vaginal pain and vaginal dryness in...

Pharma Guy's insight:

"Have you ever wanted to be part of the food and drug regulatory process?," asks the FDA in its search for a Few Good Consumer Representatives to Serve on Advisory Committees; http://sco.lt/75ZP97. "Do you have a history of public interest or a passion for consumer advocacy? Do you have experience analyzing scientific data? If you answered “Yes,” here’s your opportunity to become an advocate for consumers!"


Also, read "The Power and the 'Science' of Patient Input"; http://sco.lt/5v9Q7l 

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FDASIA Deadline UpDate: "Nearly All" Deliverables Completed, Says FDA

FDASIA Deadline UpDate: "Nearly All" Deliverables Completed, Says FDA | Pharmaguy's Insights Into Drug Industry News | Scoop.it

From Margaret A. Hamburg, M.D.


Anniversaries are a time for stock-taking and today, on the second anniversary of the Food and Drug Administration Safety and Innovation Act or FDASIA, I’m pleased to report on the progress we’ve made implementing this multi-faceted law.


To date, we have completed nearly all of the deliverables we had scheduled for the first two years after FDASIA became law. And many of the new authorities under FDASIA are already having a positive impact on health. It’s difficult to cover all of our FDASIA work, but here are some highlights:

Pharma Guy's insight:


One deliverable not "completed" and not mentioned by Dr. Hamburg is the one remaining piece of social media guidance FDA promised to deliver in 2014. Find more on that here.


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Joel Finkle's curator insight, July 11, 2014 9:31 AM

FDA scores itself on their FDASIA achievements. I don't have any nitpicks, as the things I want (RPS, IDMP documentation) are all further out and dependent on external organizations.