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The FDA published a guidance for industry and its reviewers on the formal CDER and CBER procedures for resolving scientific disputes with sponsors that cannot be settled at the division level, and how to appeal issues to the office or center levels. Read More
The FDA is planning to restructure product review offices in all its centers as it moves toward a team-based approach, Commissioner Scott Gottlieb said Friday at the National Press Club. Read More
In a response to the petition, CDER Director Janet Woodcock said the company had failed to demonstrate that the launch of Roxybond would cause it irreparable injury. Read More
The FDA updated its guidance on communications with generics manufacturers to reflect the timelines agreed to in the second generation of the GDUFA program, which took effect Oct. 1. Read More
The U.K.’s National Institute for Health and Care Excellence published guidances for three drugs in four indications, recommending their use by the NHS as long as the sponsors comply with patient access programs and agreed-upon discounts. Read More
A worker benefits fund filed a lawsuit against Johnson & Johnson this week for allegedly maintaining an illegal monopoly for its Crohn’s disease drug Remicade. Read More
The European Medicines Agency is already changing its procedures in advance of the UK’s departure from the European Union in 2019, with the pending withdrawal affecting which experts the agency appoints to investigate applications for new drug approvals, the agency said. Read More