A new guidance includes preliminary estimates of backlog, application and drug master file fees under the new generic drug user fee program. However, the agency must wait for Congress to pass an FY 2013 appropriations bill or continuing resolution with language allowing it to collect the new revenue.
FDA has estimated nearly all of the generic drug user fees that sponsors and manufacturers should expect to pay when the program launches in October, but admits that some of the calculations could be complicated.
Most of the actual fee amounts are targeted for release by Oct. 31, although estimates included in a new Q&A...
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
