Agency IQ

MAY 31, 2024

and national regulators. Given the expansive and complex European life sciences regulatory landscape, we’ll be including updates from key E.U. Fill out the form to read the full article.

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Agency IQ

AUGUST 2, 2024

By Sebastian Godoy, MPH , Kirsten Messmer, PhD, RAC, Corey Jaseph, MS, RAC , Kari Oakes In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Regulations 59

FDA Law Blog: Biosimilars

MARCH 10, 2024

Hyman, Phelps & McNamara Director Larry Houck will participate as a panelist focusing on this timely topic at the Food and Drug Law Institute’s (“FDLI’s”) Legal and Practical Issues in Cannabis Regulation Conference next month. April 4th and 5th, is an in-person and virtual event. The conference, held in Washington, D.C.,

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Agency IQ

DECEMBER 1, 2023

In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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Regulations Science 59

Agency IQ

MARCH 1, 2024

and national regulators. The goal: to allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts. The goal: to allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts. Fill out the form to read the full article.

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Regulations Science 59

Agency IQ

OCTOBER 27, 2023

In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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Regulations Science 59

Perficient: Drug Development

MARCH 11, 2024

Did you miss our event or need a refresh? Watch a recap of Lisa Sherwood’s presentation at our Electric Cars + Coffee virtual event! On February 16, I had the opportunity to join my colleagues Lisa Sherwood and Kevin Espinosa in hosting our “Electric Cars and Coffee” virtual event.

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Agency IQ

AUGUST 30, 2024

By Sebastian Godoy, MPH , Corey Jaseph, MS, RAC , Kari Oakes In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations and comment periods.

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Regulations 52

Agency IQ

MAY 3, 2024

Fill out the form to read the full article.

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Regulations 52

Covalent Modifiers

APRIL 17, 2023

3c00029 The mitogen-activated protein kinase signaling cascade is conserved across eukaryotes, where it plays a critical role in the regulation of activities including proliferation, differentiation, and stress responses. Scheidt ACS Medicinal Chemistry Letters 2023 DOI: 10.1021/acsmedchemlett.3c00029

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Regulations 130

FDA Law Blog: Drug Discovery

MARCH 6, 2024

HP&M is proud to have our professionals participating in these important events. John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns.

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Advarra

FEBRUARY 22, 2024

Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the study is as safe as possible and the participants have the most up to date information so they can decide whether to continue their participation in the research study. regulations. What Does FDA Guidance Say About SAE Reporting?

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Perficient: Drug Development

SEPTEMBER 6, 2023

The regulators feel that this proposed LTD rule would: Improve the resolvability of these banking organizations in case of failure, Potentially reduce costs to the Deposit Insurance Fund, and Mitigate financial stability and contagion risks by reducing the risk of loss to uninsured depositors.

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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. The draft guidance therefore continues to “recommend” sponsors go beyond what is required in its regulations in its communications to FDA based on DMC recommendations, highlighting the tension between what FDA needs and what it wants.

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FDA Law Blog: Biosimilars

JUNE 12, 2024

The GAO Report provides an overview of the rulemaking process for OTC hearing aids, the resulting OTC hearing aid regulatory scheme, and FDA’s interaction with other agencies when regulating OTC hearing aids. The Agency “may issue technology specific regulations and guidance as new hearing technologies are approved and cleared by FDA.”

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FDA Law Blog: Biosimilars

MARCH 15, 2023

s Ricardo Carvajal will be moderating a panel on “The Use of Bioactive Substances in Food and Dietary Supplements” during the Food and Drug Law Institute (FDLI) Food and Dietary Supplement Safety and Regulation Conference. Hyman, Phelps & McNamara, P.C.’s

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Regulations Compliance FDA Production 45

FDA Law Blog: Biosimilars

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

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Regulations FDA Production Government 45

Perficient: Drug Development

NOVEMBER 27, 2023

In the dynamic environment of highly regulated industries like healthcare and financial services, leaders often balance competing goals to delight customers while cutting costs. This blog was co-authored by Carl Aridas and Joel Thimsen. Build a reliable risk management strategy using accurate estimations and predictions.

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Regulations Compliance International Science 52

Drug Channels

FEBRUARY 7, 2022

Hybrid Event March 28-29, 2022 | Philadelphia, PA www.informaconnect.com/drug-pricing-transparency. You'll be part of the important discussions on how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Drug Pricing Transparency Congress.

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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. Multiple ECHA Committees will meet in May, and the agency will also be hosting a two-day IT event.

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Agency IQ

MARCH 1, 2024

What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Under the BPR, one substance, cholecalciferol (CAS RN 67-97-0), is being considered for an exemption from the regulation’s exclusion criteria. Many events are slated to take place in March.

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Regulations Production Packaging Science 40

Drug Channels

MARCH 18, 2024

Informa Connect is thrilled to announce Pricing & Contracting USA , an innovative summit that brings together three of the life science industry’s most well-known events (Medicaid & Government Pricing Congress, Drug Pricing Transparency Congress and the Contracts & Chargebacks Summit) together for enhanced learning and networking.

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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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The Strateos Blog: Drug Discovery

DECEMBER 5, 2022

The Alliance fosters pre-competitive collaboration with members working together as equals on projects that will benefit the industry as a whole—whether it is identifying the root causes of inefficiencies, working with regulators to adopt new standards, or helping researchers implement AI effectively—and more!  The

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ASPET

AUGUST 21, 2024

This review details the onset mechanisms of drug-induced TdP, including I Kr inhibition, pharmacokinetic factors, autonomic regulation and reduced repolarization reserve. It also explores the utility of proarrhythmic surrogate markers (J-T peak , T peak -T end and terminal repolarization period) besides QT interval.

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Agency IQ

DECEMBER 1, 2023

What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Highlights of chemical regulatory activities Consultations open under the REACH and CLP regulations are coming to an end in December. Events happening next month include two ECHA meetings (i.e.,

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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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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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Agency IQ

AUGUST 2, 2024

By Alexander Gaffney, MS, RAC In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Fill out the form to read the full article.

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Agency IQ

JULY 8, 2024

BY ALEXANDER GAFFNEY, MS, RAC In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Fill out the form to read the full article.

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FDA Regulations 59

Agency IQ

MAY 3, 2024

BY ALEXANDER GAFFNEY, MS, RAC In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Fill out the form to read the full article.

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FDA Regulations 59

Agency IQ

MARCH 29, 2024

BY ALEXANDER GAFFNEY, MS, RAC In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Fill out the form to read the full article.

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FDA Regulations 59

ASPET

MARCH 20, 2024

DNA topoisomerase IIβ (TOP2β/180; 180 kDa) is a nuclear enzyme that regulates DNA topology by generation of short-lived DNA double-strand breaks primarily during transcription. 5 in part due to overexpression of microRNA-9-3p/5p impacting post-transcriptional events.

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Agency IQ

MAY 3, 2024

BY WALKER LIVINGSTON, ESQ 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.

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Regulations 59

Agency IQ

FEBRUARY 2, 2024

What we expect EU regulators to do in February 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. BY SCOTT STEPHENS, MPA | JAN 26, 2024 10:22 PM CST Highlights of upcoming chemical regulatory activities Consultations under the REACH and CLP regulations are coming to an end in February.

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Agency IQ

JANUARY 4, 2024

What we expect EU regulators to do in January 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA plays a central role in this reassignment of duties, and it would make sense for the basic regulation to be introduced at the same time as these other proposals.

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Drug Channels

SEPTEMBER 13, 2021

Delivered as a Hybrid Event In-Person: November 9-10 | Philadelphia, PA Virtual: November 16-17 www.informaconnect.com/drug-pricing-transparency. Choose how you attend with the All-Access Pass , registration to both the in-person and virtual events, or the Virtual-Only Pass. Informa Connect’s Drug Pricing Transparency Congress.

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