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 2014_register executive 2014-01-14 article Notices D09002ee1c7fa90a5 D09002ee1c7fa911e 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United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics." This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers, packers, and distributors (firms), that may either be the applicant or acting on behalf of the applicant, of prescription human and animal drug and biological products (drugs) can fulfill regulatory requirements for postmarketing submissions of interactive promotional media for their FDA-approved products. This draft guidance clarifies FDA's policies on what the Agency considers to be interactive promotional media. 79 FR 2449 https://www.govinfo.gov/app/details/FR-2014-01-14/2014-00519 2014-00519 fr14ja14-67 4160-01-P Docket No. FDA-2013-N-1430 https://www.govinfo.gov/app/details/FR-2014-01-14/2014-00519 https://www.govinfo.gov/content/pkg/FR-2014-01-14/html/2014-00519.htm https://www.govinfo.gov/content/pkg/FR-2014-01-14/pdf/2014-00519.pdf 2 p. 2449 2450 79 FR 2449 Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics; Availability; Federal Register Vol. 79, Issue NOTICE 2014-00519 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2013-N-1430 4160-01-P 2014-00519 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics." This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers, packers, and distributors (firms), that may either be the applicant or acting on behalf of the applicant, of prescription human and animal drug and biological products (drugs) can fulfill regulatory requirements for postmarketing submissions of interactive promotional media for their FDA-approved products. This draft guidance clarifies FDA's policies on what the Agency considers to be interactive promotional media.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments 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 April 14, 2014. General comments on Agency guidance documents are welcome at any time. Regarding human prescription drugs: Barbara Chong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993, 301-796-1200. Draft Guidance for Industry and Staff; Availability: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics , http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 79, no. 9 Office of the Federal Register, National Archives and Records Administration 2014-01-14 continuing daily deposited born digital 230 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-01-14 P0b002ee186dbe68b 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr14ja14 https://www.govinfo.gov/app/details/FR-2014-01-14 https://www.govinfo.gov/content/pkg/FR-2014-01-14/pdf/FR-2014-01-14.pdf https://www.govinfo.gov/content/pkg/FR-2014-01-14/xml/FR-2014-01-14.xml fdlp 2359 2580 DGPO 2014-01-14 2024-06-03 FR-2014-01-14 machine generated eng FR FR-2014-01-14 79 9