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

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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The Pharma Data

APRIL 14, 2021

with Xolair since its initial approval in 2003. By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade. Approximately 460,000 patients have been treated in the U.S. In the U.S., About Xolair.

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Perficient: Drug Development

FEBRUARY 22, 2024

I worked on many projects with them in my early career (2003-2013). At that time, their industry was driven by government regulations and tariffs. A Real-World Personal Example – Zagging to Success A successful “zag” with a great idea doesn’t need to be risky. Atlas Van Lines is in the moving and relocation industry.

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FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

It merely says that “[t]he Hatch-Waxman Act and FDA regulations set forth the criteria for listing patents in the Orange Book” and that “Brand manufacturers are responsible for ensuring their patents are properly listed.” But it is not always clear which types of patents are eligible for listing in the Orange Book.

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Agency IQ

MARCH 1, 2024

What we expect the EPA to do in March 2024 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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The Pharma Data

DECEMBER 10, 2020

The Company’s ordinary shares are listed on the regulated market of Euronext Paris under the ticker symbol “NANO.”. Any stabilization action or over-allotment shall be carried out in accordance with all applicable rules and regulations and may be undertaken on the regulated market of Euronext in Paris and on the Nasdaq Global Select Market.

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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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NIH Director's Blog: Drug Discovery

MAY 9, 2019

Similarly, when the complete human genome sequence was revealed for the first time in 2003, commentators (including me) referred to this as the moment where the book of life for humans was revealed. When NIH’s Marshall Nirenberg and his colleagues cracked the genetic code in 1961, it was called the solution to life’s greatest secret.

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Agency IQ

JULY 5, 2023

What we expect the EPA to do in July 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.

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Agency IQ

JUNE 2, 2023

The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The content of the PMI : The regulation describes, in broad terms, what must be included in the PMI. Eliminating duplication : The proposed regulations aren’t only intended to be additive.

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The Pharma Data

NOVEMBER 4, 2020

From 2003 to 2014, Mr. Thoresen was the managing director of Nycomed Pharma AS acquired by Takeda Pharmaceutical Company Limited in 2011 as part of an acquisition transaction with a total value of approximately USD $14B. SOURCE: XPhyto Therapeutics Corp. View source version on accesswire.com: [link].

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Codon

FEBRUARY 27, 2024

It was March 2003, and an unfortunate 33-year-old, known only as patient YY, was suffering from intense diarrhea. Whether new sprays are made using copper, carbon nanotubes, or cellulose, though, they will have to vault two hurdles: testing outside of the laboratory, and regulation. Read it on our website here.

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The Pharma Data

OCTOBER 19, 2020

Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell. Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP).

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

2003) , and Biogen lnt’l v. The PTO’s not-even-specious-argument, citing what certainly appears to us to be absolutely irrelevant case law, such as Novartis AG v. Ezra Ventures LLC, 909 F.3d 3d 1367 (Fed. 2018) , Arnold Partnership v. Rogan , 246 F. 2d 460 (E.D. Banner Life Sciences LLC, 956 F.3d 3d 1351 (Fed.

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The Pharma Data

DECEMBER 15, 2020

Founded in 2003, Athenex, Inc. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, through 13 subsidiaries, with about 1,800 employees. Total revenues in 2019 were 908.4 million euros. For more information, please visit almirall.com. About Athenex, Inc.

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The Pharma Data

NOVEMBER 9, 2020

About NANOBIOTIX: www.nanobiotix.com Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.

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BMG Labtech

MARCH 8, 2023

In fact, metabolism should not be considered as a self-regulating entity that is independent of other biological pathways. Cell metabolism and disease Metabolic perturbations and metabolic reprogramming are associated with common human diseases. On the contrary, cell metabolism affects or is affected by a multitude of processes.

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Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

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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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Agency IQ

SEPTEMBER 29, 2023

What we expect the EPA to do in October 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.

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Regulations Compliance Science Marketing 40

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. Gottlieb also worked in leadership positions at FDA and CMS from 2003 to 2007.

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The Premier Consulting Blog

APRIL 27, 2023

In 2003, the original eCTD was adopted by health authorities and sponsors both in the U.S. Technical Conformance Guide HL7 Version 3 Implementation Guide: Regulated Product Submission, Release 1 This group created the Common Technical Document (CTD), thereby standardizing applications submitted to regulatory authorities. FDA eCTD v4.0

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Packaging FDA International Pharmaceuticals 52

The Premier Consulting Blog

AUGUST 21, 2024

August 2021: [link] Pharmaceutical Regulations in Japan: Drug Development: [link] [link] [link] Stability conditions for WHO Member States by Region, March 2021: [link]

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Policy Prescription

MARCH 12, 2021

Existing law, as found in the Medicare Prescription Drug Modernization and Improvement Act of 2003 (MMA), only allows wholesale drug importation from Canada (if safety and savings are certified by the HHS Secretary). State of Reform does a nice job covering this bill, but this post gives some underlying and important history.

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Codon

NOVEMBER 1, 2024

A first draft was published in 2003; it was a patchwork of sequenced DNA from multiple people. It demands protocols, regulations, and collaborative efforts between human beings. Department of Energy and National Institutes of Health initiated a 15-year plan to map ‘the sequence of all 3.2

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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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Regulations Compliance Government Science 40

FDA Law Blog: Biosimilars

JANUARY 9, 2024

After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires. Major barriers still persist.

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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. A state-regulated cannabis industry better protects consumers than the illicit market or the unregulated intoxicating hemp-derived marketplace. January 29, 2024).

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Drug & Device Law

JUNE 1, 2023

2003) (a court that “permits [an expert] to testify as an expert without first determining whether he or she has a sufficient basis” is “abdicating its evidentiary gatekeeping responsibilities”) (footnote omitted). 2003); see also Sherwin-Williams Co. 2003) (“Section 490.065.3 Prentice v. Dalco Electric, Inc. , Curi , 817 A.2d

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). 2003), review denied (Cal.

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. 644 (2003), but not to Pike. Ogden , 22 U.S. Wisconsin , 228 U.S. 115 (1913), and Savage v. 501 (1912).

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Drug & Device Law

FEBRUARY 20, 2023

2003), aff’d , 810 N.Y.S.2d Another decision in the same case reached the same result: In the United States, the FDA regulates the sale of medical devices. Lederle Laboratories recognized that courts, generally, are “reluctan[t]. . . to determine whether a proposed alternative drug would have received FDA approval.” 2d 839, 851 (N.Y.

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