Bla regulatory pathway
Outlook Therapeutics, Inc.
Outlook Therapeutics intends to complete development of ONS-5010 for submission to the FDA as a new BLA under the 351(a) PHSA regulatory pathway for the treatment of wet AMD and also has plans to submit for regulatory approvals in Europe, the United Kingdom and Japan, as well as other countries.
Mylan N.V.
The Biologic License Application (“BLA”) regulatory pathway was created to review and approve new applications for drugs that are typically produced in living cells. In 2010, in the context of the adoption of the Patient Protection and Affordable Care Act — H.R. 3590 and the Healthcare and Education Reconciliation Act of 2010 — H.R ...
Investor Relations | Allena Pharmaceuticals, Inc.
The FDA has advised us that it agrees that, if positive, biomarker data on 24-hour UOx excretion in URIROX-1 and URIROX-2 would be used for a BLA submission for reloxaliase using the accelerated approval regulatory pathway.
Attachment E CDRH Final Guidance Cover Sheet
While the potential regulatory pathway for your device may be a topic of discussion in a Pre-Sub interaction, device classification is accomplished in accordance with Section 513 of the FD&C Act. You can obtain additional information about how your device might …
Mylan Investor Relations | Mylan N.V.
The Biologic License Application (“BLA”) regulatory pathway was created to review and approve new applications for drugs that are typically produced in living cells. In 2010, in the context of the adoption of the Patient Protection and Affordable Care Act — H.R. 3590 and the Healthcare and Education Reconciliation Act of 2010 — H.R ...
[DOCX File]stem art
https://info.5y1.org/bla-regulatory-pathway_1_ee381c.html
The REGROW Act- an urgent demand for a new FDA regulatory pathway to accelerate safe cell therapies. ... Even more to the point, after 15 years of requiring cell therapy developers to pursue approval through the BLA process, the FDA has not yet issued a single approval. This bottleneck has real-world consequences for patients every day who ...
MiMedx Group, Inc. | Investor Overview
In order to conform to this regulatory guidance, MiMedx is pursuing several indications under the BLA pathway, although there can be no assurance that we will obtain a BLA and may ultimately decide not to pursue a BLA for certain products or indications. See . Risk Factors - “ Obtaining and maintaining the
ir.outlooktherapeutics.com
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
protalixbiotherapeutics.gcs-web.com
On May 28, 2020, we, together with Chiesi, announced the submission on May 27, 2020 of a BLA to the FDA for pegunigalsidase alfa for the treatment of adult patients with Fabry disease via the FDA’s Accelerated Approval pathway. The BLA submission includes a comprehensive set of preclinical, clinical and manufacturing data compiled from our ...
Investor Relations | Allena Pharmaceuticals, Inc.
Although we have reached alignment with the FDA on the design of URIROX-2, our second pivotal Phase 3 trial of reloxaliase in patients with enteric hyperoxaluria, and our strategy to pursue a BLA submission for reloxaliase using the accelerated approval regulatory pathway, the clinical data we generate from our Phase 3 clinical program and/or ...
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