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The EMA’s Committee for Medicinal Products for Human Use is recommending approval for six drugs within the EU and another for export-only from EU countries. Read More
In response to industry concerns about the FDA’s handling of biosimilar applications, the agency is looking to establish a dedicated biosimilar review unit as part of BsUFA reauthorizations. Read More
An FDA official is taking steps to clarify labeling requirements for generic drugmakers, as frequent deficiencies can lead to increased review cycles and labeling that differs from reference products. Read More