Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 40

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 40
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 Strategy, or REMS, as part of an NDA or BLA approval for products with serious safety concerns to help ensure
that the benefits of the product outweigh the risks. The REMS plan may contain post-marketing obligations of the sponsor to train prescribing
physicians, monitor off-label drug use, and perhaps the conduct of Phase 4 follow-up studies and/or patient registries to ensure the continued
safe use of the drug.

As part of the approval process, the FDA must
inspect and approve each manufacturing facility. Among the conditions of approval is the requirement that a manufacturer’s quality
control and manufacturing procedures conform to cGMP. Manufacturers must expend significant time, money and effort to ensure continued
compliance, and the FDA conducts periodic inspections to certify compliance. It may be difficult for our manufacturers or for us to comply
with the applicable cGMP, as interpreted by the FDA, and other FDA regulatory requirements. If we, or our contract manufacturers, fail
to comply, then the FDA may not allow us to market products that have been affected by the failure.

If the FDA grants approval, the approval will
be limited to those conditions and patient populations for which the product is safe and effective, as demonstrated through clinical studies
and as reflected in the approved labeling. Further, a product may be marketed only in those dosage forms and for those indications approved
in the NDA or BLA. Certain changes to an approved NDA or BLA, including, with certain exceptions, any significant changes to labeling,
may require prior approval of a supplemental application before the drug may be marketed as changed. Any products that we manufacture
or distribute pursuant to FDA approvals are subject to continuing monitoring and regulation by the FDA, including compliance with cGMP
and the reporting of adverse experiences with the drugs. The nature of marketing claims that the FDA will permit us to make in the labeling
and advertising of our products will generally be limited to those specified in FDA approved labeling, and the advertising of our products
will be subject to comprehensive monitoring and regulation by the FDA. Drugs whose review was accelerated may carry additional restrictions
on marketing activities, including the requirement that all promotional materials are pre-submitted to the FDA. Claims exceeding those
contained in the approved labeling will constitute a violation of the FDCA. Violations of the FDCA or regulatory requirements at any time
during the product development process, approval process, or marketing and sale following approval may result in agency enforcement actions,
including withdrawal of approval, recall, seizure of products