How to make it by sunset
Executive Summary
Companies must respond in writing to FDA pediatric written requests before the FDAMA pediatric exclusivity provision sunsets on Jan. 1, 2002, in order to qualify for six-month exclusivity, CDER Associate Director of Pediatrics Dianne Murphy, MD, informed a West Chester University pharmaceutical scholarship conference May 12. A bill to reauthorize exclusivity has been introduced in the Senate (1"The Pink Sheet" May 14, p. 21)
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Pediatric sunset
FDA clarifies that "at a minimum, companies must have been issued a written request" before Jan. 1 in order to qualify for pediatric exclusivity under the current law. Sponsors do not have to respond to the request before the sunset date to qualify (1"The Pink Sheet" May 21, In Brief)
Pediatric sunset
FDA clarifies that "at a minimum, companies must have been issued a written request" before Jan. 1 in order to qualify for pediatric exclusivity under the current law. Sponsors do not have to respond to the request before the sunset date to qualify (1"The Pink Sheet" May 21, In Brief)
Pediatric Labeling Negotiations Limited To 6 Months In Reauthorization Bill
Negotiations for pediatric labeling changes would be limited to six months under a proposed bill to reauthorize the pediatric exclusivity provisions.