FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

The wide range of assertions supporting or opposing Health and Human Services’ (“HHS’”) recommendation that the Drug Enforcement Administration (“DEA”) reschedule cannabis federally from schedule I to schedule III would lead an outsider to conclude that commenters are referring to different substances. Letter to U.S.

Regulations 59

Regulations Production FDA Approval Marketing 59

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. FDA , 727 F.

FDA 52

FDA FDA Approval Doctors Production 52

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. FDA , 727 F. 1, 6 (D.D.C.

FDA Approval 59

FDA Approval FDA Doctors Production 59

Drug & Device Law

JULY 24, 2023

2019) (“ PATDC82 I ”), because the third-party payor (“TPP”) plaintiffs were allowed to misuse RICO to pursue what was essentially a garden variety inadequate warning case – that the drug Actos increased the risk of bladder cancer. What’s worse, the fraud on the FDA claim, if brought under state law, would be preempted by Buckman Co.

Testimonials 52

Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

MARCH 31, 2022

The underlying liability allegations are little different than what has been asserted in the Zantac MDL, which we described here: Zantac is a drug that has been around, in branded or generic form, since 1983. In other words, the generic manufacturers are not allowed to change the FDA-approved label. 2022 WL 53700, at *3.

Government 52

Government Production FDA Approval FDA 52

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.

FDA 59

FDA Production FDA Approval Regulations 59

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. The drugs at issue are life-saving antiretroviral drugs used to treat patients with HIV. But how did we get here? This is a major issue.

FDA Approval 105

FDA Approval Drugs Production FDA 105