The Pharma Data

MAY 15, 2023

Before joining Nestlé he served as CFO at Takeda Pharmaceuticals, one of the largest publicly listed companies in Japan, between 2013 and 2015, and CFO at Millicom, a NASDAQ listed global mobile phone operator based in Luxembourg, between 2008 and 2013. Urs Riedener, was CEO of Swiss consumer goods company EMMI Group between 2008 and 2022.

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Vial

FEBRUARY 23, 2024

In 2022, the global market value of patient portals within the clinical research and healthcare industries was estimated to be US $2.9 In 2008, prior to ARRA and the HITECH Act, only 10% of hospitals in the United States had transitioned from paper-based methods into EMRs, primarily due to their exorbitant set-up costs.

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Agency IQ

AUGUST 2, 2024

What we expect EU chemical regulators to do in August 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Other consultations ending in August include two addressing potential candidates for substitution and exemption conditions under the Biocidal Products Regulation (BPR), including for the substance DBNPA.

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Codon

JULY 17, 2024

He’s an educator, molecular florist, and founder at Binomica Labs , a small biology research group focusing on providing an alternative to “exposure-driven and marketing-centric research.” In 2008, I began to lurk on do-it-yourself biology forums. That’s just a recipe for disaster.

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Agency IQ

MAY 31, 2024

What we expect EU chemical regulators to do in June 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Another consultation is closing this month on a draft implementing regulation that is amending the label format for fluorinated greenhouse gases (F-gases) under the new F-gas Regulation (EU) 2024/573.

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Agency IQ

AUGUST 30, 2024

What we expect EU chemical regulators to do in September 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. A full list of chemical events is also scheduled for September, as regulators and regulatory affairs professionals return to work after the summer holidays.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.”

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Agency IQ

APRIL 19, 2024

The conduct and infrastructure of clinical trials is heavily regulated, and updates to the methods, approaches, designs, or technologies employed can have regulatory implications. In particular, regulations in both the U.S. In particular, regulations in both the U.S. KEVIN BUGIN will serve as C3TI Director.

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Agency IQ

JUNE 21, 2024

Commission proposes guidelines to flesh out the newly finalized Variations Regulation This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

110-316 (2008) and by Section 1135 of the FDA Safety and Innovation Act (“FDASIA”), Pub. We have the utmost respect for the seriousness with which FDA’s scientists and regulatory professionals approach these matters, and are confident that no one at FDA wants to see potentially dangerous drugs on the market. 112-144 (2012).

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Agency IQ

MAY 3, 2024

What we expect EU chemical regulators to do in May 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. On May 29-30, the agency will host ECHA IT Days , a two-day conference held in Helsinki, Finland dedicated to all things related to information technology and chemical regulations.

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Agency IQ

NOVEMBER 20, 2023

Sentinel Update: PDUFA projects, ARIA sufficiency and building out a method for causal inference FDA’s Sentinel Initiative, the post-market, real-world data surveillance system, is nearing the end of its current five-year strategic plan. The Sentinel Initiative was kicked off in 2008 under the FDA Amendments Act (FDAAA).

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Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness. Interestingly, Merck & Co.

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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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The Pharma Data

OCTOBER 15, 2020

John Hospital, researchers compared 649 patients from two cohorts: a recent cohort (2017–2019) from the RECOVER III post-market approval (PMA) study, after the widespread adoption of the best practice of placing Impella pre-PCI, and a cohort from before PMA (2008–2014) when the practice of placing Impella pre-PCI was not yet widely adopted.

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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

AUGUST 23, 2024

ECHA issues guidelines for enforcing mixture classification based on bridging principles ECHA has issued a new guide for national enforcement authorities (NEAs), clarifying the tiered approach to mixtures classification under the CLP Regulation and strategies for reviewing duty holders’ classifications of hazardous mixtures.

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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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Perficient: Drug Development

FEBRUARY 22, 2024

Several books have been written on the concept, and many more refer to it when discussing differentiation and disruption within marketing and product development. It’s common that people view novel and innovative, first-to-market groups as having great ideas. The analogy of the “red ocean” of a saturated market drives home his point.

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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. Regan, Case No: 1:16-cv-00364-CRC (D.D.C.

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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

AUGUST 23, 2024

By Laura DiAngelo, MPH | Aug 22, 2024 10:13 PM CDT Intro: Pre-Determined Change Control Plans in medical device regulation Post-market updates to authorized medical devices may, or may not, require a new submission to the FDA. This trio of documents are known collectively as the Modifications Guidance documents.

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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

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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Agency IQ

FEBRUARY 15, 2024

The regulation of BPA in the EU today BPA has been jointly registered (as a full registration) under REACH with over 60 registrants manufacturing or importing the substance in the tonnage band at or above 1,000,000 metric tons per year. B1) BPA’s regulation across so many sectors affecting different parts of the supply chain (i.e.,

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Drug Target Review

SEPTEMBER 26, 2023

5,6 The range of CNS-related toxicities encountered throughout drug development and post-market approval is vast, and includes abuse liability, suicidal ideation, emesis, sleep disorder and cognitive dysfunction to name a few. Ther Innov Regul Sci. Regul Toxicol Pharmacol RTP. 2008 Mar;153 Suppl 2(Suppl 2):S1-209.

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Agency IQ

JUNE 2, 2023

Proposal for a regulation Initiative entry Chemicals – making best use of EU agencies to streamline scientific assessments Adoption is planned for second quarter of 2023 The European Green Deal aims to move towards a ‘one substance, one assessment’ process for chemical safety assessments.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156 and interpretive case law, if an applicant for patent term extension has multiple NDA approvals of a product, PTE applicant can only rely on ‘a’ (single) regulatory review period for a first permitted commercial marketing or use of a product to establish the requirements for patent term extension. Patent Nos.

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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

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. The FDA recently concluded its work on a proposed rule focused on PMI.

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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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The Pharma Data

AUGUST 17, 2021

FDA has approved finerenone for marketing authorization in the U.S. Finerenone has been submitted for marketing authorization in the EU and other countries worldwide based on the positive data from FIDELIO-DKD and these applications are currently under review. Since launch in 2008, more than 86 million patients have been treated.

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The Pharma Data

MAY 15, 2021

So much so that studies have shown your brain can regulate force production without you ever having to move a muscle. Which is why I’ve made a publishing deal: we could test this low cost offer in a few places, and if it does well we keep it on the market and go wide with it. They understand that your mind drives your movement.

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Drug & Device Law

DECEMBER 21, 2023

2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. Remember Riegel ( 2008+1 )? FDA , 78 F.4th 4th 210 (5th Cir. CooperSurgical, Inc. 2023 WL 6216933 (S.D.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. no[r] a marketing product” under Lanham Act). 2008 WL 11344752, at *2 (D. April 22, 2008); Isham v. 2008 WL 2622791, at *4 (N.D. 2008) (all quoting and following Pierson definition of product).

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Drug & Device Law

OCTOBER 23, 2023

Back in 2008, the United States Supreme Court held, in Riegel v. 312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. Medtronic, Inc. , 360k(a) (emphasis added). at 328 (citation omitted). outlaw abortion,” among other things.

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Drug & Device Law

JUNE 2, 2022

This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v. See this post on one of our decisions from 2008.) the state action would be preempted. Strickland , 531 F.3d 3d 406 (6th Cir. Bartlett , 570 U.S. 472 (2013). (See Humble , 753 F.3d 3d 905 (9th Cir.

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