FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

The closest FDA has come is in a 2003 preamble noting that patents that claim finished dosage forms—which can include “metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems”—should be listed in the Orange Book, suggesting that a patent that claims both the drug substance and the delivery device should be listed.

FDA 105

FDA Biosimilars FDA Approval Drugs 105

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. The earliest tenured is John Bartels, who served as Administrator from 1973 to 1975.

Regulations 59

Regulations Production FDA Approval Marketing 59

The Pharma Data

NOVEMBER 23, 2020

Food and Drug Administration (FDA) approved the combination of ipilimumab and nivolumab (Yervoy and Opdivo) for the first-line treatment of MPM based on mOS of 18.1 months (Baas 2020), and this is expected to serve as a benchmark for further approvals. .” Recently, the U.S. References.

FDA Approval 40

FDA Approval Trials Treatment Virus 40

Agency IQ

JUNE 2, 2023

Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. Information included in the PMI : FDA intends that the PMI would “highlight the most important information that patients need to know to help them use their prescription drug products safely and effectively.”

FDA 40

FDA FDA Approval Regulations Production 40

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The meeting’s outcome did not receive a rave review from former FDA Commissioner Scott Gottlieb, who led the agency between 2017 and 2019.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

New Drug Approvals

JULY 10, 2023

If FDA approved, it will join other previously-approved “-gepant” drugs [ rimegepant ] and [ ubrogepant ] as an additional treatment alternative for patients with migraine, particularly those for whom traditional triptan therapy has proven ineffective. and > 300 mg/mL at lower pH pKa 4.8 2021 Jan 1;31:127624.

Clinical Trials 40

Clinical Trials Treatment FDA Trials 40

Drug & Device Law

JANUARY 30, 2023

Moran , 536 U.S. Walsh , 538 U.S. Albrecht , 139 S.Ct.

FDA 72

FDA Regulations Production Government 72

Drug & Device Law

APRIL 18, 2022

at *3 – which means, as we’ve discussed before , a manufacturer cannot include warnings about such off-label uses absent specific FDA approval. 2003 WL 1785795, at *13 (D. Apparently, the “no warnings” issue arose because physician in Rennick put the product to an off-label use, id. 3d 203 (5th Cir. 2008); Herzog v.

Testimonials 59

Testimonials Production FDA Approval FDA 59

Drug & Device Law

JANUARY 4, 2024

The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). 2003); Birdsong v.

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

MAY 26, 2023

A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. 644 (2003), but not to Pike. Other state laws affecting FDA-approved drugs are more likely to have the required protectionist bent.

Regulations 59

Regulations Production FDA FDA Approval 59