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.”
FDA Law Blog
JUNE 28, 2022
1) to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or. (2) The relevant CSA provision provides: (a) Unlawful acts. Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally —. (1) 21 U.S.C. §
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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). The Second Circuit’s Interpretation of the AKS and its Mens Rea Element. Background.
FDA Law Blog
AUGUST 4, 2022
Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Whether the Beneficiary Inducement Statute (BIS) is relevant to interpreting the AKS (essentially, no). Background. Pfizer set the price of tafamidis at $225,000 for each one-year course of treatment.
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.
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