2003, Biosimilars, FDA Approval and Research

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Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

FDA proposes that the PMI include four key headings: The drug name, important safety information, common side effects and directions for use. Curiously, there is no direction for the patient to seek out the full FDA-approved labeling.

FDA

FDA FDA Approval Production Regulations

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

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. Rescheduling increases the ability to research cannabis to determine the physical and mental impacts of cannabis use. The earliest tenured is John Bartels, who served as Administrator from 1973 to 1975.

Regulations

Regulations Production FDA Approval Marketing

Drug Discovery Digest

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

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