viernes, 2 de noviembre de 2018

FDA-Hepatitis Updates: Draft Guidance for Chronic Hepatitis B Virus Infection-Developing Drugs for Treatment

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of drugs and biologics for the treatment of chronic hepatitis B virus (HBV) infection from the initial investigational new drug application (IND) through the new drug application (NDA)/biologics license application (BLA) and postmarketing phases. The guidance includes general considerations for nonclinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and phase 3 safety and efficacy trials. The guidance discusses phase 3 trial design considerations and efficacy endpoints for the development of combination therapies for the treatment of chronic HBV infection. Drug development considerations for specific subpopulations such as patients coinfected with hepatitis D virus or human immunodeficiency virus and pediatric HBV-infected patients are also included.

You can find the entire document at:

Submit either electronic or written comments on the draft guidance by January 2, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. You can find the Federal Register Notice (Document Number 2018-23951) at:

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

Elizabeth Thompson
Division of Antiviral Products
Food and Drug Administration
Michael Stanfield Jr.
Division of Antiviral Products
Food and Drug Administration

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