FDA In Brief: FDA seeks input on development and evaluation of abuse-deterrent formulations of central nervous system stimulants

Generic Drugs Offices and Divisions

August Egg Company of Hilmar, CA is recalling 1,700,000 dozen brown cage free and brown certified organic eggs, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and other

C3TI aims to increase experience in Bayesian statistical methods in simple trial settings across sponsors, CDER clinical reviewers, and CDER statisticians, including deepening an understanding of their applicability, opportunities, and challenges.

McNeil Healthcare, LLC, Las Piedras, PR 483 issued 11/02/2010

NDA and BLA Calendar Year Approvals

Clinical Investigator (Sponsor)