• Regulatory NewsRegulatory News

    When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains

    When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when can this occur? On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision. Explained simply: Refuse-to-file actions allow FDA to inform a sponsor as quickly as possible of deficiencies in an NDA or ...
  • Regulatory NewsRegulatory News

    FDA Wants Sponsors of Biotech Products to Assess Product's Impact on Environment

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has released a new draft guidance document meant to clarify when companies need to conduct an Environmental Assessment (EA) for gene therapy and other recombinant products. Background Under 21 CFR 25 of the Code of Federal Regulations , most pharmaceutical and biotechnology companies are required to submit EAs as part of their approval package. The assessments are gene...
  • AdvaMed, Device Companies Claim FDA's 510(k) Pre-Review Guidance Lacks Objectivity

    Several prominent members of the medical device industry, including its largest trade group, have voiced their concerns about a new guidance document released by the US Food and Drug Administration (FDA) that would consolidate and expand the agency's pre-review policies for some medical device applications submitted through the 510(k) pathway. The guidance, Refuse to Accept (RTA) Policy for 510(k)s , is intended to make it easier for FDA to filter out inadequate sub...