United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2013_register executive 2013-07-24 article Notices D09002ee1c7fb34fd D09002ee1c7fb357e United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Pre-Launch Activities Importation Requests (PLAIR)." This draft guidance describes FDA's policy regarding requests for the importation of unapproved finished dosage form drug products by applicants preparing products for market launch based on anticipated approval of a pending new drug application (NDA) or an abbreviated new drug application (ANDA). This draft guidance also applies to biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research. This draft guidance further describes the procedures for making these requests and the criteria that FDA will consider in granting such requests. 78 FR 44572 https://www.govinfo.gov/app/details/FR-2013-07-24/2013-17768 2013-17768 fr24jy13-77 4160-01-P Docket No. FDA-2013-D-0836 https://www.govinfo.gov/app/details/FR-2013-07-24/2013-17768 https://www.govinfo.gov/content/pkg/FR-2013-07-24/html/2013-17768.htm https://www.govinfo.gov/content/pkg/FR-2013-07-24/pdf/2013-17768.pdf 2 p. 44572 44573 78 FR 44572 Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability; Federal Register Vol. 78, Issue NOTICE 2013-17768 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2013-D-0836 4160-01-P 2013-17768 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Pre-Launch Activities Importation Requests (PLAIR)." This draft guidance describes FDA's policy regarding requests for the importation of unapproved finished dosage form drug products by applicants preparing products for market launch based on anticipated approval of a pending new drug application (NDA) or an abbreviated new drug application (ANDA). This draft guidance also applies to biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research. This draft guidance further describes the procedures for making these requests and the criteria that FDA will consider in granting such requests.

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 September 23, 2013. Submit either electronic or written comments concerning the proposed collection of information by September 23, 2013. Marybet Lopez, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4286, Silver Spring, MD 20993-0002, 301- 796-3110; or Stella Notzon, Office of Regulatory Affairs, Division of Import Operations, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 301-796-6678. Draft Guidance for Industry; Availability: Pre-Launch Activities Importation Requests , http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 78, no. 142 Office of the Federal Register, National Archives and Records Administration 2013-07-24 continuing daily deposited born digital 460 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-07-24 P0b002ee18598b349 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr24jy13 https://www.govinfo.gov/app/details/FR-2013-07-24 https://www.govinfo.gov/content/pkg/FR-2013-07-24/pdf/FR-2013-07-24.pdf https://www.govinfo.gov/content/pkg/FR-2013-07-24/xml/FR-2013-07-24.xml fdlp 44419 44870 DGPO 2013-07-24 2024-06-03 FR-2013-07-24 machine generated eng FR FR-2013-07-24 78 142