Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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Codon

JULY 14, 2024

In 1940, Charles Drew—the first African-American researcher to earn a doctor of medical science degree at Columbia University—developed an ingenious method for separating and storing plasma , the liquid part of blood that contains essential proteins that promote clotting and regulate blood pressure.

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The Pharma Data

NOVEMBER 4, 2020

REDUCE-IT ® PCI results presented in October 2020 showed through post hoc subgroup analyses that patients in the REDUCE-IT study who had stenting, bypass or other forms of percutaneous cardiovascular intervention (PCI) experienced significantly reduced rates of ischemic events when treated with VASCEPA. commercial team.

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The Pharma Data

MAY 13, 2021

WITHOUT doctors, physical therapists or chiropractors. Our Unique Solution Has Been Featured All Over The Media, From Hallmark, The Doctors, Atlanta Live & Arizona Midday…. I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! And then got my Doctor of Pharmacy (Pharm.

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The Pharma Data

JUNE 18, 2021

Key secondary endpoints were rates of uMRD (<10-4 by 8-color flow cytometry), response per iwCLL, adverse events (AEs), as well as progression-free survival (PFS). The safety profile of the combination was generally consistent with known adverse events for ibrutinib and venetoclax individually and no new safety signals emerged.

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The Pharma Data

JUNE 18, 2021

3 treatment-emergent adverse events (AEs) were neutropenia (34.9%), infections (17%), and diarrhea (10.4%) for I+V; neutropenia (49.5%), infections (11.4%), and thrombocytopenia (20%) for C+O. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. Call your doctor for medical advice about side effects.

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The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD.

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The Pharma Data

MAY 4, 2021

down 21%, driven by a negative impact from the COVID-19 pandemic resulting in a decline in patient visits to doctors for preventative health purposes, as well as the loss of patent protection in the U.S. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

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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. Adequate directions for use were something given to doctors by manufacturers, not by doctors to anyone else.

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Drug & Device Law

APRIL 14, 2023

The only cases the defendant cited in support of its preemption argument were cases in which courts held that plaintiffs’ labeling claims related to Class II devices were preempted because the FDA “had specifically defined the content required to the devices label through a regulation or a specific requirement in a special controls document.”

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Drug & Device Law

MARCH 19, 2024

Plaintiff did not allege that the design of the clips deviated from the FDA approved design. Nor did plaintiff allege that the clips were manufactured in a way not approved by the FDA. Hodges was about the evidentiary use of actual adverse event reports for “notice” – not failure to report. Brannon , 707 A.2d

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Drug & Device Law

FEBRUARY 11, 2024

FDA litigation that is now before the Supreme Court. Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. We were hardly alone. Studnicki J, Harrison D.J., Longbons T.,

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Drug & Device Law

NOVEMBER 17, 2022

The complaint did “not allege that the warnings Defendants provided deviated in any way from the language and warnings that the FDA approved. Nor could she claim that defendants “were required to give any warning or instruction beyond the labeling the FDA approved.” emphasis original). Bye-bye warning claims.

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Drug & Device Law

APRIL 20, 2023

This dive into the latest on reproductive rights in the context of challenges to FDA’s regulation of a prescription medication is an instance where we wish we had not been right with some of our predictions. The identified injuries were even more unusual in light of the lack of standing to challenge approval. That is unusual.

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Drug & Device Law

APRIL 17, 2023

He criticized the warnings for not mentioning bleeding from eye – where he claimed injury – even though the defendant warned generally that “[b]leeding problems are common” adverse events with this drug. Plaintiff alleges that information from the “FAERS Public Dashboard” and clinicaltrials.gov, which are maintained by the FDA. . . .

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Drug & Device Law

SEPTEMBER 26, 2023

The court’s decision to take judicial notice of defendant’s FDA-approved labeling has not changed. Prescription drug failure to warn claims are preempted unless plaintiff pleads a labeling deficiency that could have been changed via the Changes Being Effected (“CBE”) regulation. Meaning they don’t fit the bill.

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