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Skipping ahead because you feel fine at the current dose is one of the most common protocol errors

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FDA Commissioner Robert Califf added his voice to the dispute, reminding all holders of drug approvals that they are obligated to ensure that patent listings comply with statutory and regulatory requirements and to substantively respond to statements of dispute provided under the FDAs patent listing dispute process. The move is further evidence of increasing scrutiny of the activities of the pharma industry by the FTC, which has also been taking a tougher stance on mergers and acquisitions in the sector and launching investigations into the role of pharmacy benefit managers in the medicines supply chain.