Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

DECEMBER 15, 2020

The researchers regulated the abnormal immunological memory processes found in these patients. Daratumumab already is approved for the treatment of multiple myeloma. Scientists at Charité, University Medicine Berlin , have been able to use daratumumab to successfully treat two female patients who have systemic lupus erythematosus.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

FDA Law Blog: Biosimilars

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

Regulations 69

Regulations FDA Licensing Licensing 69

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

FDA Law Blog: Biosimilars

MAY 5, 2024

FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

FDA 95

FDA Regulations Treatment Licensing 95

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 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.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). & Com.

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59

Drug & Device Law

SEPTEMBER 7, 2023

For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use. The FDCA “does [not] mention any other specific procedure, device, cosmetic, or medication it instructs the FDA to regulate.” emphasis in original).

FDA Approval 59

FDA Approval FDA Licensing Licensing 59