{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on generic paliperidone palmitate extended-release injectable suspension, entitled \"Draft Guidance on Paliperidone Palmitate.\" The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for paliperidone palmitate extended-release injectable suspension.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/07/01/2016-15663.html","cfr_references":[],"citation":"81 FR 43209","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 6, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2007-D-0369"],"dockets":[{"supporting_documents":[{"title":"PSG_212725 - Draft Guidance on Entrectinib re Product-Specific Guidances; 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Draft Guidance for Industry; Availability","toc_doc":"Bioequivalence Recommendations for Paliperidone Palmitate","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}