Within the review teams at FDA, there is the sentiment that the broadened safety authorities granted under the FDA Amendments Act allow the agency to approve drugs that it previously would have considered unapprovable, as an office director in the Center for Drug Evaluation and Research makes clear in the review documents for Takeda’s gout therapy Uloric (febuxostat).
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Clarity on payer responses to controversial vaccine recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices may be coming.
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
