FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10

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Codon

APRIL 23, 2024

The yeast cells synthesize lots of sugars to regulate their internal osmotic pressure and also attach sugars to proteins to stabilize them against damage caused by the perchlorates. The entire planet is basically a desiccant, akin to those white packets found in packages of beef jerky that say “Do not eat.”

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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The Pharma Data

JUNE 18, 2021

The global burden of IBD: from 2015 to 2025. 2015 Dec;12(12):720-7. SYRIZI (risankizumab) [Package Insert]. The Economic Cost of Crohn’s Disease and Ulcerative Colitis. Access Economics Pty Limited. Available at: [link]. Accessed April 9, 2021. Nat Rev Gastroenterol Hepatol. doi: 10.1038/nrgastro.2015.150. AbbVie Inc.

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Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

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The Pharma Data

JUNE 18, 2021

The global burden of IBD: from 2015 to 2025. 2015 Dec;12(12):720-7. SKYRIZI (risankizumab) [Package Insert]. A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov.

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Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

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Agency IQ

MARCH 29, 2024

What we expect the EPA to do in April 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 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.

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Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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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.

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Agency IQ

DECEMBER 1, 2023

What we expect the EPA to do in December 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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LifeSciVC

APRIL 27, 2023

Much of our success springs from being nimble and pragmatic on the journey: by optimizing areas we know work well and adapting to ever-changing landscapes in the capital markets, therapeutics spaces, and laws and regulations (e.g.,

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Agency IQ

FEBRUARY 23, 2024

This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017. Some speakers and participants mentioned that many patients are looking for efficacy when they participate in phase I trials, so what can sponsors and regulators do to achieve that? A lot of times the lower dose wins, right?

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The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. In a 2015 study published in the Journal of Traditional and Complementary Medicine…. Along with the amount of estrogen-regulating DIM that he added as well. So go ahead and choose your discounted package of HB5 right now…. So what’s the fix here?

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Agency IQ

FEBRUARY 2, 2024

What we expect the EPA to do in February In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. The Agency expects to issue a final rule later in 2023.

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Agency IQ

JANUARY 4, 2024

What we expect the EPA to do in January 2024 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

JULY 28, 2023

October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

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Drug & Device Law

JULY 31, 2023

135 (Winter 2015) (citation and quotation marks omitted). 2015), held that digital files for 3D printing were not material things as required to invoke the Tariff Act of 1930. 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2015) (collecting cases).

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Drug & Device Law

DECEMBER 29, 2023

Indeed, even the weird alternatives the plaintiff advocated, such as “point of sale” signs and DTC advertising (assuming these were Prop 65 remedies at all), were still FDA-regulated labeling. Alcozar didn’t buy it, since the particular regulations did not even apply to the clinics and health care providers that plaintiffs were targeting.

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Drug & Device Law

SEPTEMBER 12, 2022

The plaintiffs in Pfaff , who opted out of the settlement, had originally brought suit in California federal court back in 2015. Preemption turns on the availability of the FDA’s changes being accepted (“CBE”) regulation, 21 C.F.R. Both propositions are well recognized, but Pfaff ties them together in one neat package.

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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. 25, 2023), is one we have been talking about for a long time. As detailed here , the decision in Yates v. Ortho-McNeil-Janssen Pharms., 3d 281 (6th Cir.

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Drug & Device Law

FEBRUARY 24, 2022

Because § 343-1(a) applies only to foods, the court’s detailed analysis of the relevant labeling regulations is not directly applicable to drug and device cases. 2015) (Gorsuch, J.). Implicitly relying on 21 U.S.C. § 2022 WL 464149, at *1. 2022 WL 464149, at *4. Precisely so. 2d at 777; accord, e.g. , Blankenship v. Medtronic, Inc. ,

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