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How does FDA exclusivity work?

Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements. A new drug application (NDA) or abbreviated new drug application (ANDA) holder is eligible for exclusivity if statutory requirements are met.

What is the best pharmaceuticals for children act and pediatric research equity act?

PREA, first enacted in 2003, gives the FDA the authority to require drug manufacturers to complete studies in children for the same adult indications when the drugs are expected to be used in a substantial number of children. BPCA and PREA were both reauthorized by Congress in 2007.

What are the criteria for a PREA waiver?

FDA may grant a waiver from PREA requirements to study a medicine in children when (1) necessary studies are impossible or highly impracticable; (2) there is evidence strongly suggesting that the product would be ineffective or unsafe in all pediatric age groups; or (3) the product does not represent a meaningful

What is the difference between BPCA and PREA?

PREA requires studies only on indication(s) under review; BPCA studies relate to an entire moiety and may include unapproved and different indications. Studies for orphan indications are exempt from PREA; however, written requests may be issued for orphan indications under BPCA. PREA and BPCA cover drugs and biologics.

What is the pediatric Research Equity Act of 2003?

The Pediatric Research Equity Act amends the federal Food, Drug, and Cosmetic Act to authorize the FDA to require pediatric studies of drugs or biologics when other approaches are insufficient to ensure that the products are safe and effective for use in children.

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How do I get pediatric exclusivity?

How to Qualify for FDA Pediatric Exclusivity Obtain a Written Request containing a detailed description of the studies and the time frame needed for completion. Submit study reports (typically in the form of a new drug application, as a supplement to an approved application, or as an amendment to a pending application).

What is the FDA PREA commitment?

PREA gives FDA the authority to require pediatric studies in certain drugs and biological products. Studies must use appropriate formulations for each age group. The goal of the studies is to obtain pediatric labeling for the product.

What was the Pediatric Research Equity Act in 2003 directed at?

To amend the Federal Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration to require certain research into drugs used in pediatric patients. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1.

What is a pediatric written request?

A Written Request (WR) is a legal document laying out the conditions under which a pediatric clinical trial should be conducted.

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