Advertisement

FDA to Revamp Rare Disease Efforts

The US government agency vows to improve the way it facilitates the development and approval of drugs for orphan diseases.

By | September 12, 2011

WIKIMEDIA, TOM VARCOWith growing interest from the pharmaceutical and biotech industries in addressing diseases that afflict fewer than 200,000 Americans, the US Food and Drug Administration is going to ramp up its efforts to help drug makers develop treatments for rare diseases, the agency announced in a draft, five-year plan released last week. Starting late next year, the FDA's Center for Drug Evaluation and Research will bolster its Rare Disease Program (RDP) by providing pharmaceutical and biotech companies specialized training on the development of drugs for rare, or orphan, diseases and improving its outreach to rare disease patient organizations. According to the draft plan, the agency will also add five new positions to the staff of the RDP, retool the way it evaluates the success of the program, and hold public meetings to hear concerns and suggestions from stakeholders in rare disease drug development. On October 14th of this year, the FDA will hold a public meeting to hear feedback on the draft recommendations.

Advertisement

Add a Comment

Avatar of: You

You

Processing...
Processing...

Sign In with your LabX Media Group Passport to leave a comment

Not a member? Register Now!

LabX Media Group Passport Logo

Comments

Avatar of: Anonymous

Anonymous

September 19, 2011

Is the date of the meeting reported in this Nutshell correct?

Avatar of:

Posts: 0

September 19, 2011

Is the date of the meeting reported in this Nutshell correct?

Avatar of:

Posts: 0

September 19, 2011

Is the date of the meeting reported in this Nutshell correct?

Advertisement

Popular Now

  1. Opinion: Making Progress by Slowing Down
  2. A Case of Sexual Ambiguity, 1865
    Foundations A Case of Sexual Ambiguity, 1865

    This year marks the 150th anniversary of an autopsy report describing the first known case of a sexual development disorder.

  3. Influential Cancer Biologist Dies
  4. Image of the Day: Colorful Corn
Advertisement
Advertisement
Life Technologies