Pediatric Prozac Phase IV Commitments Will Test Exclusivity Incentive
Lilly's Phase IV commitments for additional research on pediatric use of Prozac will serve as a high-profile test of FDA's pediatric exclusivity incentive
You may also be interested in...
FDA clears Lilly's Prozac (fluoxetine) for treatment of major depressive disorder and obsessive compulsive disorder in children seven to 17 Jan. 3. The company received additional market exclusivity from February 2001 until August 2001 for conducting the pediatric trials. As a Phase IV postmarketing commitment, Lilly will "evaluate any potential impact of fluoxetine on long-term growth in children," an FDA 1talk paper says...
The retail pharmacy trade associations are urging the House leadership to delete language creating an adverse event reporting hotline from the pediatric exclusivity bill
House Commerce oversight of FDA agenda will be influenced by WLF president and new staffer Slobodin.
HOUSE COMMERCE OVERSIGHT OF FDA AGENDA WILL BE SHAPED BY WLF President and Legal Studies Division General Counsel Alan Slobodin, who is set to become counsel to the House Commerce Committee on Jan. 24. Although an employee of the full committee, Slobodin is likely to play a role in the development of hearings in the Oversight Subcommittee.