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 letter is signed by six former DEA administrators and five former Directors of National Drug Policy. The earliest tenured is John Bartels, who served as Administrator from 1973 to 1975.

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Drug & Device Law

AUGUST 28, 2023

In our line of work, much of what we do depends on the continuing validity of what the FDA does with respect to prescription medical products. 341 (2001), is so important. It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions.

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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. It prevents plaintiffs in prescription medical product liability litigation from making collateral attacks on in-force FDA decisions. That’s why Buckman Co.

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Drug & Device Law

JULY 24, 2023

What’s worse, the fraud on the FDA claim, if brought under state law, would be preempted by Buckman Co. 341 (2001). Without any consideration of what actual doctors did for actual patients with actual diseases, all that was proven was the maxim “garbage in, garbage out.” Plaintiffs Legal Committee , 531 U.S.

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Drug & Device Law

MARCH 31, 2022

In other words, the generic manufacturers are not allowed to change the FDA-approved label. 2001) (“irrespective of the theory of recovery. . . Thus, the two sides of the Baltimore opinion remind us of the classic “ The Strange Case of Doctor Jekyll and Mister Hyde.” E.g. , Ford Motor Co. 2d 362, 370 (Md.

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Drug & Device Law

FEBRUARY 11, 2024

Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. Doctors Who Perform Abortions: Their Characteristics & Patterns of Holding & Using Hospital Privileges,” 6.

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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. The court also assumed that physicians naturally would prescribe the “newer” TAF once the FDA approved it. at *48-*50. at *31, *32.

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