Source: https://www.federalregister.gov/articles/2013/05/09/2013-11006/draft-guidance-for-industry-on-charging-for-investigational-drugs-under-an-investigational-new-drug?source=govdelivery
Timestamp: 2015-07-05 13:21:55
Document Index: 370868214

Matched Legal Cases: ['§ 312', '§ 312', 'art 312', 'art 312', '§ 312', '§ 312']

Federal Register | Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New Drug Application-Questions and Answers; Availability
Dates: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 8, 2013.
-27117 (2 pages)
Document Number: 2013-11006
Shorter URL: https://federalregister.gov/a/2013-11006 Regulations.gov Docket Info
Draft Guidance for Industry on Charging for Investigational Drugs Under an IND – Qs & As; Availability
FDA is announcing the availability of a draft guidance for industry entitled “Charging for Investigational Drugs Under an IND—Qs As.” In 2009, FDA amended its regulation concerning charging for investigational new drugs under an IND (August 13, 2009; 74 FR 40872). The new regulation, which went into effect on October 13, 2009, removed paragraph (d) of § 312.7 (21 CFR 312.7) and replaced it with new § 312.8. The new regulation is intended to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the three types of expanded access for treatment use described in subpart I of 21 CFR part 312, and to clarify what costs can be recovered for an investigational drug. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance entitled “Expanded Access to Investigational Drugs for Treatment Use—Qs As,” which is intended to provide information about FDA's implementation of its expanded access regulations (21 CFR part 312, subpart I).
Since § 312.8 has been in effect, FDA has received numerous questions about how it is implementing the regulation and interpreting various provisions. Consistent with the goal of clarifying the requirements for charging for an investigational drug and the types of costs that can be recovered, FDA is providing a draft guidance in a question and answer format, addressing the most frequently asked questions and answers about charging for investigational drug under an IND.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on charging for an investigational drug under an IND. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in § 312.8 have been approved under OMB control number 0910-0014.
Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default, or http://www.regulations.gov.