Common Sense for Drug Policy Blog

JANUARY 5, 2024

Part of this 'performance' has to do with adapting to the different temporal demands of the labor market—in other words, the management of sleep and wakefulness. Historians trace the use of coffee back to the fifth century, in the Sufi monasteries of Mocha, now known as Yemen (Weinberg and Bealer 2001 ). As Crary ( 2013 , p.

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Agency IQ

AUGUST 16, 2024

Lykos Therapeutics’ New Drug Application (NDA) for MDMA capsules to treat post-traumatic stress disorder (PTSD) A lengthy regulatory history: The initial investigational new drug application for midomafetamine was filed in 2001. Lykos (formerly MAPS PBC) met with the agency in 2016 for the End of Phase 2 meeting.

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Agency IQ

JANUARY 26, 2024

Samples retained for testing should be kept under similar storage conditions and within the same container-closure system in which the drug is marketed. In 2001, the American Medical Association (AMA) conducted a survey of relevant stakeholders – including PhRMA, the U.S.

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Agency IQ

JULY 12, 2024

Next, the European Commission collected data from marketing authorization holders, suppliers and national competent authorities for the selected medicines. Marketing authorization holders also were asked to provide a supply chain risk assessment evaluating potential vulnerabilities and the expected economic viability of the medicine.

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Drug & Device Law

JULY 24, 2023

341 (2001). The drug is still on the market, and it has other risks that the FDA has found significantly more serious – requiring a boxed warning – than a three-one hundredths-of one-percent (0.0003) increase in absolute incidence of bladder cancer. the relationship between [plaintiff] and its pharmacy benefit manager. . .

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Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth Laboratories, Inc. , 2d 839, 851 (N.Y.

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Drug & Device Law

JANUARY 4, 2024

purchase, marketing, promotion, . . Alabama State Board of Pharmacy , 61 F.4th Okuley’s Pharmacy & Home Medical , N.E.3d development, clinical testing or investigation, distribution, purchase, marketing, promotion, sale, purchase, or use” of an immune covered countermeasure. 247d-6d(b)(8). Strike two. Strike three.

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