FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

There has been no evidence that marijuana’s schedule should change since the last rescheduling review in 2016. FDA has not approved marijuana for medical use because no double-blind, published studies show safety and efficacy for raw marijuana. In other words, no rescheduling.

Regulations 59

Regulations Production FDA Approval Marketing 59

Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. In GenBioPro, Inc.

FDA Approval 111

FDA Approval Pharmacy FDA Production 111

Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

MAY 26, 2022

About three and a half years after that, she complained of new pain in her left hip, was worked up, and had a left hip revision surgery in December 2016. But it was consistent with the rate in the approved IFU at the time and plaintiff had no evidence that she or her doctor relied on the undifferentiated rate.

Doctors 59

Doctors FDA FDA Approval Production 59

Drug & Device Law

FEBRUARY 11, 2024

On appeal, the Fifth Circuit overturned the District Court’s nullification of the FDA’s approvals of both branded and generic versions of mifepristone but affirmed that court’s voiding of both the 2016 risk evaluation and mitigation strategy (“REMS”) and 2021 non-enforcement decision that allowed telemedicine prescription of mifepristone.

FDA 59

FDA Production FDA Approval Regulations 59

Drug & Device Law

NOVEMBER 7, 2022

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease ( Fabry Disease ). Genzyme Corp. Genzyme Corp. ,

Production 72

Production FDA Approval Packaging Doctors 72

Drug & Device Law

FEBRUARY 5, 2024

2016) (pro se dismissals “should generally be without prejudice”)). Beaver II points out, as did we, that the FDA did not act because of her condition – her only basis for causation was “because her doctor recommended that she stop taking [the drug] due to her disease,” and afterwards her condition allegedly improved.

FDA Approval 52

FDA Approval FDA Pharmaceutical Companies Doctors 52

Drug & Device Law

FEBRUARY 16, 2024

First up was preemption of the design defect claim, and the court made short work of this: [I]t is uncontroverted that Cialis is an FDA-approved prescription medication which, under federal law, Defendant is prohibited from altering its formulation without prior FDA approval. Allied Mut. 2d 262, 266 (9th Cir.

Testimonials 52

Testimonials FDA Approval FDA Doctors 52

Drug & Device Law

APRIL 20, 2023

Back when the Dobbs decision had been leaked but not yet issued, we offered that the decision would open the door to a range of challenges to FDA-approved drugs for medical abortion and emergency contraception, along with a wide range of other regulated medical products. That is unusual.

FDA 59

FDA FDA Approval Doctors Treatment 59

Drug & Device Law

JUNE 28, 2022

June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications. 660, 664 (1962).

FDA Approval 116

FDA Approval FDA Regulations Drugs 116