Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Following this process, FDASIA directed the FDA to submit a report to Congress summarizing its findings.

FDA 40

FDA Regulations Production Packaging 40

Drug & Device Law

DECEMBER 29, 2023

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. Express and implied preemption operate independently ( see Buckman ), thus the express Prop 65 saving clause was irrelevant. Preemption.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

JANUARY 9, 2023

Then, the decision makes a hash of the relevant administrative record, ignoring what the preemptive FDA regulations said in favor of material from the Federal Register that never actually made it into the regulations themselves. The FDA also promulgated an acetaminophen-specific OTC regulation. 201.326(a)(1).

Regulations 59

Regulations Nurses FDA FDA Approval 59