Drug Target Review

APRIL 7, 2025

Haemoglobin A1c (HbA1c) is a validated surrogate endpoint for the reduction of microvascular complications associated with diabetes mellitus; reduced HIV-RNA levels serve as an endpoint for HIV disease control; and a reduction in low-density lipoprotein (LDL) cholesterol is used as an endpoint indicating lower likelihood of cardiovascular events.

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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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Agency IQ

MARCH 29, 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

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

FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. The answer to that is still no, the current state of world and governmental events notwithstanding.

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Compliance Regulations FDA Government 66

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

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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Regulations Science 59

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

Drug Patent Watch

MARCH 4, 2025

Pharmacovigilance is the practice of collecting, analyzing, and responding to reports of adverse events associated with medications. By monitoring adverse event reports, we can quickly respond to emerging safety concerns and take corrective action to protect patients. But why is pharmacovigilance so important?

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Advarra

NOVEMBER 14, 2024

The DSMB’s primary responsibilities include : Monitoring patient safety: Ensuring participants are not exposed to undue risk and adverse events are promptly identified and addressed. A globally diverse DMC ensures the trial adheres to local regulations while maintaining high ethical standards.

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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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Regulations FDA Production Drugs 64

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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Regulations Science Research Marketing 52

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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Clinical Trials Regulations Trials International 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: Biosimilars

FEBRUARY 27, 2025

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. This is achieved through firsthand insights, real-world examples, and case studies from FDA-regulated products. You can access the conference brochure and sign up for the event here.

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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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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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Regulations Compliance 52

Conversations in Drug Development Trends

DECEMBER 19, 2024

While the agenda remained the same across both events, the conversations revealed key regional distinctions and global perspectives on how genetic testing, ethics, and operational challenges are addressed. In-Vitro Diagnostic Regulation and The FDAs Final Rule The WODC U.S.

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Clinical Trials Regulations Drugs Trials 52

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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Elrig

MARCH 25, 2025

Prof Rory Johnson, Associate Professor, University College Dublin, and Dr Shalini Andersson, Vice President Nucleic Acid Therapeutics, AstraZeneca will lead this years event focussed on drugging the undruggable.

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RNA Bioinformatics Science Pharmacokinetics 59

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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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

Alta Sciences

NOVEMBER 4, 2024

We anticipated potential hazards and recognized and evaluated all potential exposure events to mitigate risk. Identifying exposure events early on—particularly for the dispensing of the API into the vehicle—enabled our experts to implement appropriate containment measures.

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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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Clinical Trials Trials FDA Regulations 105

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

BMG Labtech

DECEMBER 20, 2024

The amounts of critical enzyme molecules and enzyme concentrations for example may be controlled by the regulation of the rate of protein synthesis and degradation as well as the regulation of gene expression. Such events may impact the control of gene expression and enzyme activities and lead to changes in metabolism in bacteria.

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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

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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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

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

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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Regulations Government Compliance International 40

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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