Policy Prescription

JANUARY 31, 2022

state boards of pharmacy to properly regulate pharmacies that irresponsibly and too often illegally profited from opioid drug sales to patients. Despite the law requiring the reporting of suspicious orders, the Gazette-Mail reported that between 2001-2012 the board received only two reports , both from Cardinal Health.

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The Pharma Data

DECEMBER 15, 2020

As the world’s first PPAR pan agonist that completed two confirmatory phase III clinical trials, Chiglitazar Sodium has shown significant and long-lasting hypoglycemic effects in a series of clinical studies, as well as other comprehensive effects including significant insulin sensitization and blood lipid regulation.

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. A state-regulated cannabis industry better protects consumers than the illicit market or the unregulated intoxicating hemp-derived marketplace. January 29, 2024).

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Drug & Device Law

AUGUST 28, 2023

341 (2001), is so important. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. The Doctors therefore sustain a concrete injury when they are forced to divert time and resources away from their regular patients. That’s why Buckman Co. Plaintiffs Legal Committee , 531 U.S. FDA , 727 F.

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Drug & Device Law

SEPTEMBER 11, 2023

In our line of work, much of what we do depends on the continuing validity of how the FDA regulates prescription medical products. 341 (2001), is so important. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. That’s why Buckman Co. Plaintiffs Legal Committee , 531 U.S. FDA , 727 F.

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Drug & Device Law

AUGUST 22, 2022

She also tried to sue three new defendants – a doctor, a medical society and the FDA itself. 341 (2001). What the offending “component” or “material” was isn’t stated, nor how anything was “inconsistent” with some unidentified “regulation” or “requirement.” Plaintiffs Legal Committee , 531 U.S. 2019 WL 6766574, at *3.

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Drug & Device Law

JANUARY 12, 2024

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)—about a year later. This novel duty has implications far beyond FDA-regulated products.

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