FDA Law Blog
NOVEMBER 6, 2022
Pfizer manufactures tafamidis (sold under brand names Vyndaqel and Vyndamax), a breakthrough treatment for a rare, progressive heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Background.
FDA Law Blog
JUNE 28, 2022
21-5261, 597 U.S. _ (2022), the Supreme Court ruled that the government must prove — beyond a reasonable doubt — that a prescriber knew or intended that a prescription was not lawful in order to subject that prescriber to criminal penalties under the federal Controlled Substances Act (CSA). United States, No. 21 U.S.C. § 841 (emphasis added).
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FDA Law Blog
AUGUST 4, 2022
Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. On June 27, 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Background. The Lesson of this Case.
The IP Law Blog
MARCH 2, 2021
es the threat posed to companies that rely on third-party manufacturers. Considering the importance of Chinese manufacturing to global trade, the Chinese legal system and its evolving trademark enforcement system will likely cause companies to get creative. Romag solidi?es Summary of the Supreme Court’s Opinions.
SCOTUSBlog
FEBRUARY 28, 2022
The Controlled Substances Act makes it unlawful for “any person knowingly or intentionally … to manufacture, distribute, or dispense” a controlled substance, “[e]xcept as authorized by this subchapter.”
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