FDA Law Blog: Biosimilars

JANUARY 18, 2024

At that time, the Agency allowed it to stay on the market under a program that tested edible portions of pigs, a method FDA now claims is not sufficient. The EU prohibited it in 1999, almost immediately after FDA approved the testing methods at issue here, and Canada banned it in 2006.

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The Premier Consulting Blog

DECEMBER 28, 2023

The FDA may grant a waiver if the requirement is not stipulated by the Federal Food, Drug, and Cosmetic (FD&C Act) or if it is not necessary for the protection of human subjects. [3] The sponsor must also obtain FDA approval for a significant risk device investigation by submitting an IDE supplement. Available at [link]. [2]

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The Pharma Data

DECEMBER 18, 2020

2006 May; 47(5): S1-S132. Related Articles: Roxadustat FDA Approval History. Am J Kidney Dis. Bikbov B et al. Global, regional, and national burden of chronic kidney disease, 1990–2017: A systematic analysis for the Global Burden of Disease Study 2017. The Lancet 2020; 395(10225):709–33. . Source link.

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The Pharma Data

APRIL 4, 2023

Since launching the first biosimilar in Europe in 2006, Sandoz has proven biosimilars create early and expanded patient access to life-altering medicines while increasing healthcare savings and creating competition that fuels innovation and development of new and enhanced treatments in areas of unmet need.

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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.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. link] [13] A user’s guide to lorlatinib.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. link] [13] A user’s guide to lorlatinib.

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Vial

JUNE 12, 2024

In addition, regulatory agencies like the FDA published PRO guidelines for industry as early as 2006 and increasingly encourage using PROs in trials. Role of PROs in drug approvals A recent review sought to comprehensively characterize the inclusion of PROs and regulatory considerations in FDA-approved novel oncology drugs.

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The Pharma Data

JANUARY 17, 2021

Guardant Health has achieved CE mark approval as well as U.S. Guardant360 ® tests are used by oncologists around the world to guide treatment decisions across solid tumor cancers, and by pharmaceutical companies and academic researchers in clinical trials to accelerate precision medicine drug development.

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The Pharma Data

SEPTEMBER 9, 2020

ENSPRYNG is the first and only FDA-approved subcutaneous, self-administered medicine for NMOSD and the first medicine for NMOSD that is designed to target the interleukin-6 receptor, which is believed to play a key role in the inflammation associated with this disorder.”.

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The Pharma Data

JANUARY 18, 2021

When Lucentis ® (Ranibizumab) received FDA approval in late June 2006, the new macular degeneration drug was celebrated as a major medical breakthrough. Ranibizumab and other anti-VEGF agents have had a dramatic impact on the development of therapies for these blinding disorders.

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The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. 2017;34(8):1989–2006. 14 In August 2019 , RINVOQ received U.S. Shrestha S., Atopic Eczema: Itching for Life Report. Accessed on April 20, 2021. Pipeline – Our Science.

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Agency IQ

JULY 8, 2024

To address this problem, the FDA eventually issued a proposed rule in April 2006 , seeking to codify many of its previously issued recommendations. After all, reasoned the FDA, FDASIA’s streamlined approval process enabled medical gas manufacturers to secure the equivalent of an approved new drug application.

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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. CHPA considered the original studies to be sound and instead found issues with the newer studies.

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Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. 9 Gilead has launched other voluntary licenses in the past.

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Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. Auto Owners Ins.

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Drug & Device Law

SEPTEMBER 22, 2023

It is fair to say that Bexis co-founded this blog (in 2006!) in part to aid the cause of medical device and pharmaceutical manufacturers , targets in our lawsuit-obsessed country. 379r(e) product liability savings clause Id. at 1283-87.

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Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. 2006), aff’d by equally divided court , 552 U.S.

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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.” 2006), app.

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Drug & Device Law

FEBRUARY 2, 2023

2006) (reversal concerned warning issues); Blackmon v. Texas has a rebuttable presumption that FDA-approved prescription drug labels are adequate, and Plaintiff here is unable to rebut that presumption. Hoffman-La Roche, Inc. 2007 WL 4042757, at *3 (N.D. 15, 2007); McNeil v. Wyeth , 2005 WL 544222, at *6 (N.D. 3d 364 (5th Cir.

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Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications.

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Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir.

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Drug & Device Law

MAY 26, 2022

They also had to have been made between the May 2006 PMA approval and the June 2007 implant, and been relied upon by the implanting surgeon or the plaintiff. (We Plaintiff claimed the implanter was misled during a November 2006 BHR training course he attended in England. “But at *7 (citing the case discussed here ).

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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. 2006) (rejecting distinction between “a case of no warning as opposed to an inadequate warning”), aff’d , 526 F.3d Even then Rennick ’s rationale didn’t do a very good job.

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Drug & Device Law

MARCH 22, 2022

The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval. The analysis for failure to warn involving a vaccine is the same as for a prescription drug.

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