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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
The FDA is proposing to extend review times to enable more communication between the agency and sponsors to increase the number of first cycle approvals for biosimilars. Read More
Generic drug applicants need to get their bioanalytics right when demonstrating bioequivalence to avoid costly delays or outright rejection by the FDA, an agency official warns. Read More