The list below are forms for the biologicals industry.
For a complete list of forms, see: Resources
Guidance and resources
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GuidanceRelease on non-conforming biologicals is only permitted under prescribed circumstances and for an individual patient. Access to the request form and instructions are within the guidance document.
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FormsThis form guides you through the classification of biologicals and captures sufficient information about your product for us to provide advice
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FormsProposal form for a new Approved Cell and Tissue Name (ACN)
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FormsApplication form to apply for biologicals (priority applicant) determination