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What is BPCA 6 month exclusivity?

BPCA (FDCA 505A) offers pediatric drug sponsors an extended market exclusivity period of six months to encourage growth in pediatric drug research. This six-month exclusivity extends other regulatory exclusivities and patents when the sponsor conducts a written request study.

What is Section 501 of the Food Drug and Cosmetic Act?

Section 501(a)(2)(B) of the FDC Act stipulates that a drug is considered adulterated (poorer in quality by adding another substance) if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with

What is the patent term extension for pediatric exclusivity?

To encourage innovator pharmaceutical companies to conduct additional research on safety and effectiveness for pediatric patients, the United States has enacted separate provisions for granting a six-month extension of patent term known as pediatric exclusivity.

What is the 505A of the Federal Food Drug and Cosmetic Act?

Section 505(A) of The Modernization Act enabled FDA to: Issue Written Requests for pediatric studies prior to approval of a new drug application if FDA has determined that information related to the use of the drugs in the pediatric population may produce health benefits.

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. In turn, the Written Request has the benefit for the sponsor of extending the marketing exclusivity of a drug before expiry of patent protection.

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What is the 505 1 of the Federal Food, Drug, and Cosmetic Act?

Section 505-1 of the Federal Food, Drug, and Cosmetic Act (FDC Act)(21 U.S.C. 355-1) establishes FDAs REMS authority. A REMS is a required risk management strategy that can include one or more elements to ensure that the benefits of a drug outweigh its risks.

What is Section 505 B )( 2 of the Federal Food, Drug, and Cosmetic Act the act?

A 505(b)(2) application is an NDA that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant, and for which the applicant has not obtained a right of reference or use, including, for

What does Federal Food, Drug, and Cosmetic Act do?

The FDCA authorizes the FDA with the following tasks, among many others: Mandate drug manufacturers to submit evidence of new drugs safety and effectiveness before marketing and distribution to the general public. Issue and enforce quality standards for food, drugs, medical devices, and cosmetics.

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