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. The illicit marijuana market remains strong despite state laws legalizing marijuana. The letter is signed by six former DEA administrators and five former Directors of National Drug Policy.

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Drug & Device Law

AUGUST 28, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important. FDA , 727 F.

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Drug & Device Law

SEPTEMBER 11, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important. FDA , 727 F.

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Drug & Device Law

JANUARY 12, 2024

At issue was whether a product manufacturer could be liable to patients taking one drug for failing to bring a different, but allegedly safer drug to market sooner than it actually did. Instead, the plaintiffs claimed that the defendant should have developed and marketed a different drug sooner. Gilead Life Sciences, Inc. at *31-*32.

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Drug & Device Law

NOVEMBER 9, 2023

If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. The FDA is concerned, probably with reason, about its own power.

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Drug & Device Law

FEBRUARY 11, 2024

Doctors Who Perform Abortions: Their Characteristics & Patterns of Holding & Using Hospital Privileges,” 6. 9 (“Longitudinal” for the proposition that “adverse events from chemical abortion drugs can overwhelm the medical system and place ‘enormous pressure and stress’ on doctors during emergencies and complications”), at *14 n.22

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