News & Analysis as of

Pediatrics

Pediatric Healthcare Innovators Compete for Funding

by Knobbe Martens on

The FDA, according to its website, currently supports eight consortia that provide advice and funding to help commercialize technologies for pediatric care. The FDA defines “pediatric” as encompassing devices used for...more

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

by Hogan Lovells on

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

Senate Passes Long-Awaited FDA User Fee Package

Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

FDA User Fee Reauthorization Legislation Enacted by Congress

by Ropes & Gray LLP on

On July 12, 2017, the House of Representatives passed H.R. 2430, the FDA Reauthorization Act of 2017 (FDARA), and on August 3, 2017, the Senate followed suit by passing FDARA without amendment by a vote of 94-1. The President...more

When FDA Says, “It Ain’t Good Enough” – Rare Litigation over Pediatric Exclusivity

by Arnall Golden Gregory LLP on

Well, the other Boss, Bruce Springsteen, not FDA, used those words. When FDA said essentially the same thing less lyrically, but with better grammar, Amgen initiated a lawsuit on May 25, 2017, over an infrequently litigated...more

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

by Knobbe Martens on

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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