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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
Responding to changes introduced by the GDUFA II program, the FDA revised its draft guidance on sponsor pre-submissions of facility information used to assess the need for manufacturing site inspections for priority applications. Read More
Ensuring data integrity is a crucial task for drug manufacturers wishing to stay out of trouble with the FDA, a top enforcement official at the agency told an industry conference. 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
The attorneys general also seek to add Mylan President Rajiv Malik and Emcure CEO Satish Mehta as individually-named defendants in the civil antitrust cased. 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 will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read More