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

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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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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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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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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Agency IQ

MAY 3, 2024

Fill out the form to read the full article.

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Drug Target Review

SEPTEMBER 8, 2023

This receptor, referred to as retinoic acid receptor alpha (RARα), is recognised for its regulation of gene expression within the nucleus. However, recent insights indicate that it also operates beyond the nucleus, orchestrating initial events at the cell surface that trigger the activation of T cells.

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Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 2024 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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Advarra

JANUARY 13, 2023

New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g., Endpoint adjudication committees (EACs), also called clinical event committees (CECs), receive potentially identifiable research data from all over the world.

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 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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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

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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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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ASPET

MAY 22, 2024

Ligand binding to the α IIb β 3 induces a signaling termed outside-in signaling that regulate platelet spreading and clot retraction. These events are often interchangeably used to represent outside-in signaling pathway. However, the signaling entities regulating outside-in signaling is poorly understood.

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Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 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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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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Drug Discovery World

MAY 22, 2024

The keynote speakers will be Luis Serrano from the Centre for Genomic Regulation, Serrano Lab, and Maria Flocco PhD, from AstraZeneca. The Ignite Award The SLAS Ignite Award will also be presented at the event and recognises the best start-up or emerging company exhibiting within Innovation AveNEW.

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Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K.

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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

FEBRUARY 23, 2024

BY WALKER LIVINGSTON, ESQ | FEB 21, 2024 10:14 AM CST Background: RMP Under Section 112(r) of the Clean Air Act , the EPA must publish regulations and guidance regarding chemical accident protection at facilities nationwide. The agency has implemented this regulation via the Risk Management Program (RMP) rule, codified at 40 CFR Part 68.

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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

MARCH 1, 2024

What we expect European regulators to do in March 2024 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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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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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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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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Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 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.

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Regulations Clinical Trials Production Biosimilars 40

Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 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.

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Drug Discovery World

JUNE 12, 2024

Join DDW for a free event on 18 June, 3PM BST to learn more about how patient-derived organoids are revolutionising drug discovery. Before joining HUB, Dr Boj studied the role of TCF7L2 in regulating metabolism in the laboratory of Prof Hans Clevers at the Hubrecht Institute.

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Drug Discovery World

MAY 22, 2024

Join DDW for a free event on 18 June, 3PM BST to learn more about how patient-derived organoids are revolutionising drug discovery. Before joining HUB, Dr Boj studied the role of TCF7L2 in regulating metabolism in the laboratory of Prof Hans Clevers at the Hubrecht Institute.

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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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Drug Discovery World

JUNE 5, 2024

Join DDW for a free event on 18 June, 3PM BST to learn more about how patient-derived organoids are revolutionising drug discovery. Before joining HUB, Dr Boj studied the role of TCF7L2 in regulating metabolism in the laboratory of Prof Hans Clevers at the Hubrecht Institute.

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Laboratories Disease Regulations Drug Development 130

Drug Discovery World

MAY 29, 2024

Join DDW for a free event on 18 June, 3PM BST to learn more about how patient-derived organoids are revolutionising drug discovery. Before joining HUB, Dr Boj studied the role of TCF7L2 in regulating metabolism in the laboratory of Prof Hans Clevers at the Hubrecht Institute.

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Drug Discovery World

APRIL 18, 2024

The most commonly reported adverse events (AEs) in gepotidacin subjects were gastrointestinal (GI). One severe grade three adverse event was reported in each treatment arm and one unrelated serious event was reported in the gepotidacin arm. The imperative for innovative treatments has never been clearer.

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Agency IQ

OCTOBER 27, 2023

What we expect EU regulators to do in November 2023 Welcome to AgencyIQ’s roundup of upcoming regulatory activities in the EU chemicals sector. Regulation on detergents and surfactants The expert working group on detergents is scheduled to hold a meeting on November 17.

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Agency IQ

JUNE 28, 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. Fill out the form to read the full article.

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Drug Discovery World

JULY 5, 2023

These immune-humanized platforms enable researchers to test a wide range of human-specific therapeutic approaches developed to either up or down regulate immune function. Join DDW for this exclusive free event, Comparing immune-humanized platforms: Which one is best for my application? The event will take place on July 6 at 3PM BST.

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Drug Discovery World

JUNE 28, 2023

These immune-humanized platforms enable researchers to test a wide range of human-specific therapeutic approaches developed to either up or down regulate immune function. Join DDW for this exclusive free event, Comparing immune-humanized platforms: Which one is best for my application? The event will take place on July 6 at 3PM BST.

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Immune Response Laboratories Regulations Research 130