Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. and the U.K.

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Agency IQ

JUNE 7, 2024

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

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Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

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Agency IQ

SEPTEMBER 29, 2023

The Commission has prepared a draft implementing regulation for the active substance that is expected to be presented for a final vote at PAFF’s upcoming meeting. Proposal for a regulation Initiative entry Chemicals – making best use of E.U. Proposal for a regulation Initiative entry E.U. CLP revision.

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NIH Director's Blog: Drug Development

MARCH 11, 2014

ZnT8 is responsible for packaging zinc ions with insulin crystals, which are then secreted from the beta cells in the pancreas. 3] National Diabetes Education Program: Snapshot of Diabetes [4] National Diabetes Statistics, 2011. NIH/NIDDK) [5] The diabetes-susceptible gene SLC30A8/ZnT8 regulates hepatic insulin clearance.

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Agency IQ

JULY 28, 2023

The agency has kept the expected publication date for the National Primary Drinking Water Regulation (NPDWR) for six PFAS consistent between the Fall 2022 and Spring 2023 Unified Agendas [for an in-depth analysis on the proposed NPDWR, see this AgencyIQ piece ]. To contact the editor of this analysis, please email Patricia Iscaro.

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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

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. As a result, the 2011 guidance was generally seen as basic and outdated.

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Agency IQ

JULY 22, 2024

AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database. While the total number of novel drugs dipped to 37 in 2022, the agency recovered with 55 approvals in 2023, the second highest in a calendar year since 2011. [

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The Pharma Data

APRIL 28, 2021

2011 Nov;43(7):503-11. SKYRIZI (risankizumab) [Package Insert]. Accessed on April 1, 2021. Duvallet, E., Sererano, L., Assier, E., Interleukin-23: a key cytokine in inflammatory diseases. North Chicago, Ill. AbbVie Inc.

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The Pharma Data

JUNE 18, 2021

SYRIZI (risankizumab) [Package Insert]. Available at [link]. Accessed on April 9, 2021. Duvallet E, Sererano L, Assier E, et al. Interleukin-23: a key cytokine in inflammatory diseases. Nov 43(7):503-11. North Chicago, Ill. AbbVie Inc.

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The Pharma Data

AUGUST 3, 2021

The Company has initiated discussions with regulators on the Phase 3 study design for bemarituzumab, a first-in-class anti-fibroblast growth factor receptor 2b (FGFR2b) antibody for the treatment of patients with human epidermal growth factor receptor 2 (HER2) negative, FGFR2b-positive gastric and gastroesophageal junction cancer.

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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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The Pharma Data

JUNE 18, 2021

2011 Nov;43(7):503-11. SKYRIZI (risankizumab) [Package Insert]. Available at: [link]. Accessed on May 21, 2021. Duvallet, E., Sererano, L., Assier, E., Interleukin-23: a key cytokine in inflammatory diseases. North Chicago, Ill. AbbVie Inc. . SOURCE AbbVie. Source link.

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Codon

JUNE 26, 2023

I pulled them from a 2011 blog post ( oH mY goD tHat’S nOt pEEr-ReVieWeD!!! ) For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) plasmidsaurus @arjunrajlab (Regulation in biology is incredible. A typical enzyme collides with its substrate 500,000 times per second.

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Codon

JUNE 26, 2023

I pulled them from a 2011 blog post ( oH mY goD tHat’S nOt pEEr-ReVieWeD!!! ) For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) plasmidsaurus @arjunrajlab (Regulation in biology is incredible. A typical enzyme collides with its substrate 500,000 times per second.

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DNA Therapies Engineering Clinical Trials 52

Agency IQ

OCTOBER 20, 2023

In the United States, the Environmental Protection Agency (EPA) has developed a PFAS Roadmap and proposed numerous regulations for managing the effects PFAS has on the environment and human health. carpets, fabrics, and food packaging) and in specialty chemicals (i.e. BY PATRICIA ISCARO, ESQ. | OCT 11, 2023 7:05 PM CDT What are PFAS?

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The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. Meanwhile, a 2011 study from Drexel University found that African Mango: “Is effective in reducing body weight and improving metabolic parameters in overweight humans”…xxxiii. Along with the amount of estrogen-regulating DIM that he added as well.

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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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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 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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Agency IQ

OCTOBER 27, 2023

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

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Drug & Device Law

MARCH 11, 2024

Section 136v(b) mandates that states may “not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter” (emphasis added). 4th at 991, even though the relevant federal regulator (the EPA) did not require any such warning. E.g. , Riegel , 552 U.S.

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Drug & Device Law

FEBRUARY 19, 2024

For both prescription drugs and medical devices, FDA regulations provide that direct-to-patient warnings – called “adequate directions for use” – are not necessary for drugs or devices that are available only with a physician’s prescription. For drugs, the relevant regulation is 21 C.F.R. 201.100(a-c). 201.100(a-b). E.g. , 76 Fed.

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Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. OTC drugs also have an express preemption provision, but it contains an exception for Prop 65.

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Drug & Device Law

AUGUST 3, 2023

604 (2011), were still playing out. Plaintiffs did not even complain about the content of the package insert. The package insert is what most people think of as a prescription drug’s “label,” with its familiar format. Eleven years has also seen quite a bit of change in our space. Mensing , 564 U.S. Bartlett , 570 U.S.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2011 WL 13186258, at *2 (C.D. May 17, 2011) (flight simulator and associated training materials were not products subject to strict liability); Heindl v. Wells Fargo Bank , 2011 WL 1833020 (D. Iowa 2011).

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Drug & Device Law

DECEMBER 19, 2022

2019), it simply misconstrued the FDA’s rather (that’s an understatement) complicated supplemental application/changes being effected regulation, 21 C.F.R. 604, 620 (2011) (“The question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.”). Albrecht , 139 S.

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Drug & Device Law

SEPTEMBER 12, 2022

Preemption turns on the availability of the FDA’s changes being accepted (“CBE”) regulation, 21 C.F.R. c)(6-7), and, as to this drug, the defendant itself filed a CBE supplement in 2011 and was allowed to add depression as an adverse reaction. Both propositions are well recognized, but Pfaff ties them together in one neat package.

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