martes, 15 de mayo de 2018

Pediatric HIV Infection: Drug Development for Treatment; Draft Guidance

U.S. Food and Drug Administration Header

The Food and Drug Administration (FDA or Agency) is FDA is announcing the availability of a draft guidance  entitled ‘‘Pediatric HIV Infection: Drug Development for Treatment.’’ This draft guidance provides general recommendations on the development of products for the treatment of  human immunodeficiency virus (HIV) infection in pediatric patients (birth to younger than 17 years of age), including recommendations on when sponsors should initiate pediatric formulation development and begin pediatric studies to evaluate antiretroviral drug products for the treatment of HIV infection.

You can find the entire document at:

Submit either electronic or written comments on the draft guidance by July 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Submit electronic comments in the following way:
  • Federal eRulemaking Portal: Follow the instructions for submitting comments.  Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted,such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. 
  • If you want to submit a comment with confidential information that you do not wish to be made  available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’).
  • Mail/Hand delivery/Courier (for written/paper submissions):
Dockets Management Staff (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Michael Stanfield Jr.
Division of Antiviral Products
Food and Drug Administration

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