BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.
The draft guidance is an important step in clarifying the FDA’s view of endpoints to demonstrate efficacy of…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.
BIO welcomes FDA’s efforts to provide clear guidance on the regulatory and scientific framework for…
BIO submitted comments to the National Institutes of Health (NIH) regarding the Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
BIO applauds the NIH’s efforts to support and advance drug development for gene therapies, by streamlining…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-Up.
BIO agrees with most recommendations in the draft guidance…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance on Human Gene Therapy for Retinal Disorder and Human Gene Therapy for Hemophilia.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) products to treat rare diseases, including…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Human Gene Therapy for Rare Diseases.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 FDA that complex, innovative clinical trial…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs).
BIO says the comprehensive draft guidance effectively covers a range of chemistry,…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Long-Term Follow-Up After Administration of Human Gene Therapy Products.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 products over the past decade. In addition, the…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance for Industry, Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.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 chain is secure, patients are receiving authentic…
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 investigational new drug applications (INDs), new drug…