Prevents the FDA from delaying the approval of a generic drug unless a delay is necessary to protect public health.
To curb potential abuse, the U.S. Congress passed of the Federal Food, Drug, and Cosmetic Act. This law:
Under FDA regulations, any individual or entity can petition the agency to take (or refrain from taking) a specific administrative action. In the context of pharmaceuticals, these are often used to raise concerns about the safety or bioequivalence of a pending generic drug application (ANDA). 2. The "Sham" Petition Concern
The core issue discussed in the SSRN study (ID 1531776) is whether brand-name manufacturers use these filings strategically.
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Educational Resources 06C1C8EE-6564-46FE-9989-DBF4FBF086FE_1531776 - ...
APM Integrated Experience Prevents the FDA from delaying the approval of
Prevents the FDA from delaying the approval of a generic drug unless a delay is necessary to protect public health.
To curb potential abuse, the U.S. Congress passed of the Federal Food, Drug, and Cosmetic Act. This law:
Under FDA regulations, any individual or entity can petition the agency to take (or refrain from taking) a specific administrative action. In the context of pharmaceuticals, these are often used to raise concerns about the safety or bioequivalence of a pending generic drug application (ANDA). 2. The "Sham" Petition Concern
The core issue discussed in the SSRN study (ID 1531776) is whether brand-name manufacturers use these filings strategically.
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