This draft guidance is intended to provide information for industry, researchers, physicians, and patients about the implementation of FDA’s regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND) (21 CFR part 312, subpart I), which went into effect on October 13, 2009. Since 2009, FDA has received a number of questions concerning its implementation of these regulations. As a result, FDA is providing guidance in a question and answer (Q & A) format, addressing the most frequently asked questions. In separate draft guidance, FDA is providing its thinking on questions concerning its regulations on charging for investigational drugs under an IND (21 CFR 312.8), which also went into effect on October 13, 2009. Information related to charging for investigational drugs made available under expanded access programs is in that draft guidance.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact (CDER) Colleen Locicero at 301-796-2270, or (CBER) Office of Communication, Outreach and Development at 800-835-4709 or 301-827-1800.