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Continuing education programs could be a useful tool for sponsors charged with providing training and education under a REMS, according to an agency feasibility study. Read More
Writing in an FDA blog post, Commissioner Scott Gottlieb said the agency will broaden the scope of its Expanded Access Navigator tool — an information resource created by the Reagan-Udall Foundation to speed up pre-approval access to drugs. Read More
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