News & Analysis as of

Pediatrics

21st Century Cures Act Includes Several Noteworthy Mental Health and Substance Use Provisions

by Stinson Leonard Street on

The 21st Century Cures Act (Act), enacted in December 2016, has received widespread coverage for funding biomedical research and streamlining the drug approval process. The Act also includes the Helping Families in Mental...more

FDA Approves the First Insulin Pump and Glucose Monitoring System for Children

West Chester, Pennsylvania-based Animas Corporation recently announced FDA approval for the use of the Animas®Vibe® Insulin Pump and Continuous Glucose Monitoring (CGM) System for children and adolescents, ages two to...more

American Academy of Pediatrics Recommends Limits on Telemedicine

On June 29, 2015, the American Academy of Pediatrics (AAP) published a policy statement supporting the use of telemedicine in the practice of pediatrics as long as telemedicine technologies are used “in support of and...more

FDA Draft Guidance Clarifies Criteria and Process for Obtaining Rare Pediatric Disease Priority Review Vouchers

by Ropes & Gray LLP on

On November 17, 2014, the Food and Drug Administration (“FDA”) released a draft guidance entitled Rare Pediatric Disease Priority Review Vouchers, which describes an incentive program for the development of drugs intended to...more

Genetic Testing and Screening of Children: Ethics and Best Practices

by Foley & Lardner LLP on

The application of medical technology in the pediatric setting must serve the best interest of the child. Genetic testing of children and infants presents unique challenges. In contrast to the testing of adult patients, most...more

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