![]() If we authorize exportation of the drug, we notify the government of the importing country (id.). The request must also specify the quantity of the drug to be shipped and the frequency of expected shipments (id.). The written request must provide sufficient information about the drug to satisfy us that the drug is appropriate for investigational use in humans, that the drug will be used for investigational purposes only, and that the drug may be legally used by the consignee in the importing country for the proposed investigational use (see § 312.110(b)(2)(i)). Under current § 312.110(b) ( 21 CFR 312.110(b)), any person who intends to export an unapproved new drug product for use in a clinical investigation must have either an investigational new drug application (IND) or submit a written request to us (FDA). 104-180) and to modify a pre-existing regulatory program for exporting investigational new drugs. We issued the proposed rule to implement statutory changes resulting from the FDA Export Reform and Enhancement Act of 1996 ( Pub. In the Federal Register of J( 67 FR 41642), we (FDA) published a proposed rule to describe various options for exporting an investigational new drug, including a biological product. End Further Info End Preamble Start Supplemental Information SUPPLEMENTARY INFORMATION: I. Chao, Office of Policy and Planning (HF-23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 30. ![]() Start Further Info FOR FURTHER INFORMATION CONTACT: This rule is effective December 23, 2005. These provisions implement changes in FDA's export authority resulting from the FDA Export Reform and Enhancement Act of 1996 and also simplify the existing requirements for exports of investigational new drugs. The final rule describes four different mechanisms for exporting an investigational new drug product. The Food and Drug Administration (FDA) is amending its regulations on the exportation of investigational new drugs, including biological products. PART 312-INVESTIGATIONAL NEW DRUG APPLICATIONįood and Drug Administration, HHS.Are There Any Restrictions on Investigational New Drug Exports? What Changes Are Being Made to the “312 Program?” Can Investigational New Drugs Be Exported Directly to Certain Countries Without FDA Approval? Can Investigational New Drugs Be Exported If They Have Marketing Authorization? Which Countries Must Provide That Marketing Authorization? Can Investigational New Drugs Be Exported Under an IND? What Did the Proposed Rule Cover? How Many Comments Did FDA Receive? This repetition of headings to form internal navigation links Headings within the legal text of Federal Register documents. This table of contents is a navigational tool, processed from the Provide legal notice to the public or judicial notice to the courts. ![]() Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML Legal research should verify their results against an official edition of The official SGML-based PDF version on, those relying on it for The material on is accurately displayed, consistent with While every effort has been made to ensure that Regulatory information on with the objective ofĮstablishing the XML-based Federal Register as an ACFR-sanctioned The OFR/GPO partnership is committed to presenting accurate and reliable Register (ACFR) issues a regulation granting it official legal status.įor complete information about, and access to, our official publications Informational resource until the Administrative Committee of the Federal This prototype edition of theĭaily Federal Register on will remain an unofficial Each document posted on the site includes a link to theĬorresponding official PDF file on. The documents posted on this site are XML renditions of published Federal Register, and does not replace the official print version or the official It is not an official legal edition of the Federal This site displays a prototype of a “Web 2.0” version of the dailyįederal Register.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |