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Latest From Review Pathway
Agency officials don't care if DMF holder doesn't give access to its entire facility list; FDA says industry is responsible for listing all facilities that could be used as part of ANDA.
As the generic industry trade group warns shortages could emerge as number of manufacturers contracts, US FDA says many new firms gaining approvals and identifying facilities.
Oncology Center of Excellence Director Richard Pazdur says agency invites sponsors to present about molecules under development to learn more about future plans.
Health technology assessment agencies are struggling to evaluate drugs on the basis of evidence generated for early approvals, says AstraZeneca.
Bluebird Bio and Celgene have secured a place on both the EMA’s PRIME scheme and the US FDA’s breakthrough therapy designation program for their multiple myeloma CAR-T therapy, bb2121. Meanwhile, Bluebird talks about how “incredibly helpful” PRIME has been with the development of LentiGlobin for beta-thalassemia.
Deputy Office of New Drugs director says IND evaluation and post-market surveillance could be part of restructuring effort along with changes to application review.
Amid confusion about multiple priority and expedited pathways for US generic drug applications, industry asks which are a true advantage.
US FDA Commissioner says agency has necessary resources to expand priority review pathway even as multiple review cycles for generic applications remain common.
Third quarter saw record total of 26 announcements for priority review designations; drop-off now likely.
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