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. Source: Drug Industry Daily
An FDA agreement to recognize good management practice reports from eight European countries, will allow the agency to reassign investigators to high-priority areas such as India and China, an official…
The FDA finalized its guidance on developing direct-acting antivirals for chronic hepatitis C, outlining Phase III trial design options, enrollment criteria and safety evaluations for specific patient populations. Source: Drug…
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…
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…
Responding to changes introduced by the GDUFA II program, the FDA revised its draft guidance on sponsor pre-submissions of facility information used to assess the need for manufacturing site inspections…
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.…
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.…
The FDA warned four companies for illegally branding cannabidiol products as treatments for cancer and Alzheimer’s disease. Source: Drug Industry Daily
House Republicans’ $1.51 trillion tax reform bill released Thursday would repeal the orphan drug tax credit, which currently allows drug manufacturers to claim a credit equal to 50 percent of…