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Reaction is mixed to proposed legislation to revamp portions of the FDA’s drug approvals process, with generics makers already pushing back against a proposal to extend a drug’s patent protection if it serves unmet needs while others are praising parts of the bill that would speed up and simplify approvals. Read More
India’s medicines authority Wednesday detailed a proposed set of steps drugmakers must take to schedule presubmission screening meetings with drug reviewers — codifying an informal system that was launched several years ago. Read More
Europe’s brand and generic drugmakers are proposing a coordinated approach for regulators and industry to quickly identify and respond to drug shortages caused by manufacturing and quality issues. Read More
The UK’s health cost watchdog has recommended Alexion’s Soliris for the treatment of patients with atypical hemolytic uremic syndrome, a life-threatening disease that causes abnormal blood clots to form in small vessels in the kidneys. Read More
The House Energy & Commerce Committee that oversees the FDA is planning an overhaul of agency procedures to increase orphan drug development, streamline clinical trials oversight, give industry incentives to find new uses for old drugs and expand U.S. drug manufacturing. Read More