Letters, Testimony & Comments

BIO submitted comments on the Food and Drug Administration (FDA) Draft Guideline, Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. BIO appreciates FDA’s commitment to harmonization of regulatory concepts…

The following are letters, comments and statements the Biotechnology Innovation Organization wrote, organized or signed on to with regards to negogiations on the 2018 Farm Bill. 

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Adaptive Designs for Clinical Trials of Drugs and Biologics: Draft Guidance for Industry, which provides guidance to sponsors and applicants submitting…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry. BIO welcomes…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance for Industry, Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers. BIO member companies are committed to ensuring the U.S. drug supply…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-Up. BIO agrees with…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Human Gene Therapy for Rare Diseases. BIO says the guidance will assist stakeholders developing human gene therapy (GT) products to treat rare diseases. BIO reminds…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance on Human Gene Therapy for Retinal Disorder and Human Gene Therapy for Hemophilia. BIO says the guidance will assist stakeholders developing human gene therapy (GT)…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs). BIO says the comprehensive draft…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Long-Term Follow-Up After Administration of Human Gene Therapy Products. BIO says the guidance reflects the FDA’s experience evaluating the safety of gene therapy…