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Two FDA advisory committees recommended the FDA approve KemPharm’s opioid pill Apadaz, even though they rejected an abuse-deterrent label for the candidate. Read More
To bridge the gulf between the promise of biosimilars on drug pricing and the reality, payors should incentivize biosimilar utilization, a new report states. Read More
Although it is easy for drugmakers to conflate the terms “biosimilars” and “generics,” it is important for them to realize that they are not one in the same, as the policies governing biosimilars are very different from those governing small molecule drugs, an expert stresses. 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
Sponsors with pending ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said. Read More
UK regulators have fined Pfizer $14,000 for failing to explain a questionable claim meant to justify price increases on the generic seizure medication Epanutin. 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
Drugmakers and trade groups overwhelmingly want lower user fees and a clearer review process for GDUFA as the FDA looks to renew the user fees before the Sept. 30, 2017 cut-off date. 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