{"description":"Documents matching 'synthetic peptide', published on or after 01/01/2026, and from Food and Drug Administration","count":1,"total_pages":1,"results":[{"title":"Product-Specific Guidances; Revised Draft Guidances for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled \"Bioequivalence Recommendations for Specific Products\" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.","document_number":"2026-15285","html_url":"https://www.federalregister.gov/documents/2026/07/29/2026-15285/product-specific-guidances-revised-draft-guidances-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-29/pdf/2026-15285.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15285.pdf?1785242713","publication_date":"2026-07-29","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"}],"excerpts":"last announced in the \n Federal Register \n on May 22, 2026 (91 FR 30307). This notice announces revised draft product-specific guidances that are posted on FDA's website.\n \n FDA is also withdrawing the guidance for industry entitled “ANDAs for Certain Highly Purified <span class=\"match\">Synthetic</span> <span class=\"match\">Peptide</span> Drug Products That Refer to Listed Drugs of rDNA Origin” (May 2021) as it no longer reflects FDA's current scientific thinking. As noted in the Center for Drug Evaluation and Research guidance agenda, FDA plans to revise and reissue the guidance this year. \n II. Drug"}]}