federal_register: 99-28560

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
99-28560 Draft ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors;'' Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors.'' The draft guidance document applies to the manufacture of gene therapy retroviral vector products intended for in vivo or ex vivo use and to followup monitoring of patients who have received retroviral vector products. When finalized, the draft guidance document is intended to supplement the guidance document entitled ``Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy,'' dated March 1998, and a letter to Sponsors of an IND Using Retroviral Vectors, dated September 20, 1993. 1999-11-03 1999 11 https://www.federalregister.gov/documents/1999/11/03/99-28560/draft-guidance-for-industry-supplemental-guidance-on-testing-for-replication-competent-retrovirus-in https://www.govinfo.gov/content/pkg/FR-1999-11-03/pdf/99-28560.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products...

Links from other tables