Drug Channels

MARCH 4, 2025

Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCIs new live video webinar: PBM Industry Update: Trends, Challenges, and What's Ahead This event will be broadcast live on Friday, April 4, 2025, from 12:00 p.m. This event is part of The Drug Channels 2025 Video Webinar Series.

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ProRelix Research

MAY 11, 2025

Stay informed on essential regulations governing Nutraceutical Clinical Trials in India, with a detailed look at ethical standards, CDSCO oversight, and trial conduct protocols.

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Clinical Trials Regulations Trials Government 52

ProRelix Research

MAY 10, 2025

Herbal clinical trials in […] The post Essential Compliance Checklist for Regulations on Herbal Clinical Trials in USA appeared first on ProRelix Research. With the increasing popularity of herbal products for both preventive care and therapeutic intervention, the demand for rigorous scientific validation is stronger than ever.

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Clinical Trials Compliance Regulations Trials 52

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

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

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

Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. Additionally, they can provide support during FDA inspections and audits, ensuring that companies are well-prepared for these critical events.

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Compliance Pharmaceuticals Pharmaceutical Companies Regulations 94

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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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.

Regulations 52

Regulations 52

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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Clinical Trials Trials International Clinical Research 97

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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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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Drug Development Drugs Government Production 52

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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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

FDA Law Blog: Biosimilars

JUNE 2, 2025

Michael Laposata and the Association for Molecular Pathology in the recent LDT litigation, the Federal, Food, Drug, and Cosmetic Act does not authorize FDA to regulate LDTs as medical devices. Just before this decisive event, though, FDA released a relatively rare Warning Letter to a manufacturer of research use only (RUO) reagents.

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FDA Regulations Laboratories Government 64

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 Clinical Trials Regulations Production 59

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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Perficient: Drug Development

NOVEMBER 12, 2024

Health insurers are always seeking access to actionable information about their members while adhering to data privacy laws and regulations. It can support, enhance, and accelerate based on rules engines, event logs, decision rules, and simple automations of high-volume processes.

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Engineering Regulations 105

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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Drugs Clinical Trials FDA Research 52

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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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

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

Drug Channels

MAY 20, 2025

Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCIs new live video webinar: Whats Next for Retail Pharmacy: Data, Debate, and Disruption This event will be broadcast live on: Friday, June 20, 2025 12:00 p.m. This event is part of The Drug Channels 2025 Video Webinar Series.

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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

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

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

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 Regulations Treatment Licensing 111

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

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? The monies collected from the user-fee programs give FDA months of additional runway in the event of a funding lapse by Congress.

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Government Compliance FDA Licensing 76

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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