Tecovirimat, by SIGA Technologies Inc., for the treatment of smallpox

Hear about the CBER Program Review Subcommittee report; Hear about FDA’s Patient Affairs Initiative; Obtain advice to leverage existing tools and authorities, and work with stakeholders, to better address the complex scientific, public health, and technology challenges FDA faces today

sNDA for CELEBREX (celecoxib), by Pfizer, Inc., which includes the results from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial

Buprenorphine sublingual spray, by INSYS Development Company, for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate