The Food and Drug Administration (FDA or Agency) is FDA is announcing the availability of a draft guidance entitled “ Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.’’ This draft guidance provides general nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products for the prevention of sexually acquired human immunodeficiencyvirus-1 (HIV-1) infection. Specifically, this guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs to support the development of systemic drug products for the prevention of HIV-1 infection. Investigational drug products for further development as pre-exposure prophylaxis (PrEP) can include the following: (1) an oral drug product approved for the treatment of HIV-1 infection that is subsequently developed as oral PrEP; (2) an oral drug product approved for the treatment of HIV-1 infection that is reformulated as a long-acting drug product or other delivery system for PrEP; or (3) a new investigational drug product.
You can find the entire document at: https://www.fda.gov/downloads/
Submit either electronic or written comments on the draft guidance by August 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. You can find the Federal Register Notice (Document Number 2018-12761) at: https://www.federalregister.
Submit electronic comments in the following way:
You can find the entire document at: https://www.fda.gov/downloads/
Submit either electronic or written comments on the draft guidance by August 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. You can find the Federal Register Notice (Document Number 2018-12761) at: https://www.federalregister.
Submit electronic comments in the following way:
- Federal eRulemaking Portal: https://www.regulations.gov. 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
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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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