CMC reviewer, division of cellular & gene therapies at FDA, will outline a product life-cycle approach for developing potency assays for a CGT product from preclinical studies to the Biological License Application
Vaughan Clift, Ampio's Chief Regulatory Officer explained, "Satisfying the Chemistry, Manufacturing and Controls (CMC) requirements of a Biological License Application
can be one of the most complex elements of the Biologics License approval process and generally requires face-to-face meetings and teleconferences with the FDA to resolve issues.
Zostavax has been licensed in the United States for adults aged 60 years and older since 2006, and a supplemental biological license application
for the 50- to 59-year age group is under review by the Food and Drug Administration.
If successful, the resulting data will provide the basis for a Biological License Application
(BLA) in the U.
The company also announced that is has confirmed with the US Food and Drug Administration (FDA), receipt of the first portions of its Biological License Application
(BLA) for Prochymal as part of a rolling submission.
When all FDA study requirements are achieved, MP will submit a Biological License Application
(BLA) to the FDA to permit commercial sales of the products for their intended use.
The decision to proceed with an Orphan Drug Designation submission is part of Bioniche's plan to move forward with the final preparation and filing of a MCNA Biological License Application
(BLA) for U.
8221; “Pharmacometric analyses have become an increasingly important component of New Drug Application (NDA) and Biological License Application
(BLA) submissions to the US FDA to support drug approval, labelling and trial design decisions.
This guidance provides regulatory clarity and permits the submission of an MCNA Biological License Application
(BLA) for U.
The FDA approved Glassia(TM)following review of Kamada's Biological License Application
(BLA) submitted in May 2009.
He was a key leader within the Kepivance and Nplate development programs that resulted in Biological License Application
(BLA) submissions and marketing authorizations for both drug candidates.
The Supplemental Biological License Application
(sBLA) was submitted by Bristol-Myers Squibb Company to meet expected long-term demand for ORENCIA(R).