ACRP blog

FEBRUARY 11, 2025

The Health Care Compliance Association (HCCA), a nonprofit membership organization supporting healthcare compliance professionals, was founded, in part, to be your eyes and ears for compliance updates and regulatory changes. Group discounts are available; bring your team for shared learning!

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Worldwide Clinical Trials

AUGUST 15, 2023

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. You’ll have direct access to our subject matter experts and your counterparts as needed for truly collaborative development. You have the oversight you need.

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Pharmaceutical Technology

JUNE 23, 2023

The regulatory framework governing medicine development is in flux. CDMOs face growing challenges to keep up with QA and compliance.

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Drug Patent Watch

DECEMBER 10, 2024

Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in helping companies overcome these regulatory hurdles. Here, we will explore how CDMOs can provide support in regulatory compliance, ensuring that products meet the strict demands of safety, purity, and efficacy.

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Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Still, navigating such patent issues during drug development can be difficult, and Camargo can assist in finding a safe course. Ken Phelps.

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pharmaphorum

FEBRUARY 14, 2024

Discover how artificial intelligence (AI) is revolutionising the drug development process and transforming the way FDA-approved drugs are produced, ensuring compliance and optimising the supply chain. Learn more about the future of AI in pharmaceuticals.

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Cloudbyz

AUGUST 30, 2024

Given the critical nature of this data, ensuring its security and compliance with regulatory standards is paramount. Regulatory Penalties: Non-compliance with data protection regulations can lead to hefty fines and legal actions. Here are key strategies to ensure compliance within CTMS.

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ACRP blog

JUNE 30, 2023

Clinical trial billing compliance—ensuring that charges for therapies and other study-related elements are sent to the appropriate party—is a key concern for academic medical centers and other research organizations. Willenberg advised research professionals to develop a compliant billing process. Do you lose revenue in research?

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Camargo

SEPTEMBER 8, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. In the News: August 2021 Regulatory and Development Updates. In the News: July 2021 Regulatory and Development Updates.

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Pharmaceutical Technology

AUGUST 22, 2022

Fixed-dose combination (FDC) systems aim to increase patient compliance in therapies involving two or more active drugs. Procaps’ deep knowledge of gelatine formulation and scientific expertise in softgel technologies has enabled the development of a range of innovative formulations. 200x260/0 (who.int).

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Camargo

NOVEMBER 15, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. While not fatal to the application, this development is certainly a setback for the sponsor, primarily in terms of a delay in approval. Jenny Fielder.

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Camargo

OCTOBER 14, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The FDA has also recently launched the Software Pre-Certification Pilot Program to provide an efficient regulatory framework for developers of SaMD products.

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XTalks

JANUARY 30, 2025

In 2020, the US Food and Drug Administration (FDA) issued a Guidance for Industry recommending that sponsors include plans for developing age-appropriate formulations of drug products in instances where adult formulations may not be suitable for paediatric patients. One of the most significant benefits of PDFs is their ease of administration.

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Pharmaceutical Technology

MARCH 6, 2025

However, for biotech and pharma focused on developing rare disease therapies, PASS can be so much more. Post-authorisation safety studies (PASS) are often seen simply as a regulatory necessity, a checkbox that ensures ongoing monitoring of a treatments safety.

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Camargo

MAY 10, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The requirements of ClinicalTrials.gov often come as a surprise to those unfamiliar with the particulars of drug development. Co-Authors: Ken Phelps.

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Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Generic Drug Development To market a generic drug in Japan, an ANDA must be submitted to the PMDA. Conclusion The regulatory environment in Japan for generic drug development is complex and evolving.

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Cloudbyz

APRIL 25, 2023

This comprehensive guide delves into the essentials of pharmacovigilance regulatory reporting, highlighting its significance in maintaining drug and device safety, and ensuring compliance with regulatory requirements. Different types of reports have specific timelines for submission, and delays may result in regulatory actions or penalties.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2024

Biopharmaceutical involves substantial investments in research, clinical trials, regulatory compliance, and manufacturing. Pricing of biopharmaceutical medicines are influenced by various factors, and the cost of research and development (R&D) plays a significant role in determining drug prices, […]

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Cloudbyz

JUNE 16, 2023

Clinical trials are crucial for advancing medical research and developing innovative treatments. Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. They generate a vast amount of valuable data, which needs to be securely archived for future reference and analysis.

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Drug Patent Watch

DECEMBER 11, 2024

The biopharmaceutical industry has witnessed a significant surge in the number of therapeutic molecules in development, leading to a corresponding increase in the number of contract development and manufacturing organizations (CDMOs).

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Worldwide Clinical Trials

JANUARY 6, 2025

Tom Zhang, PhD, Chief Scientific Officer, Large Molecule Bioanalysis Revolutionizing Therapeutic Development with Cutting-Edge Bioanalysis Automation Cutting-edge advancements in bioanalysis (BioA) and drug R&D are reshaping the future of preventative and interventional care, but how do we harness these to their fullest potential?

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Cloudbyz

JUNE 10, 2023

21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials. Food and Drug Administration (FDA).

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. This article will delve into the importance of scientific expertise in generic drug development, highlighting the key areas where scientific knowledge is essential.

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Pharmaceutical Technology

JUNE 15, 2023

AI for drug development is rapidly streamlining R&D processes, speeding up time to market and providing a better experience for patients and providers. Learn more about the role of AI in drug development and how healthcare researchers are using it to shake up the field.

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Pharmaceutical Technology

JUNE 8, 2023

GenScript ProBio has collaborated with the New York Blood Center Enterprises’ business unit, called Comprehensive Cell Solutions (CCS), to accelerate the development and manufacture of cell and gene therapies. The core objective of the collaboration is to make the therapies affordable and accessible to patients.

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Pharmaceutical Technology

JUNE 24, 2024

Discover the key factors in selecting pharmaceutical consulting firms for regulatory compliance, strategic development, and market success.

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XTalks

DECEMBER 9, 2024

The draft also formalizes withdrawal procedures for non-compliance, including delayed studies or failure to confirm benefits. Notably, the FDA can now mandate that confirmatory trials begin before approval, ensuring proactive validation of clinical benefits.

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Pharmaceutical Technology

JANUARY 17, 2023

While tirzepatide requires weekly administration, bimagrumab is administered once every four weeks, which should have positive implications on patient compliance. The post Versanis’ bimagrumab, first-in-class obesity therapy, enters Phase IIb of development appeared first on Pharmaceutical Technology.

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Drug Patent Watch

MARCH 13, 2025

From manufacturing and quality control to distribution and regulatory compliance, the stakes are high for pharmaceutical companies looking to bring these life-changing treatments to market. Ensuring the quality and integrity of biosimilars throughout the distribution process is crucial to maintaining patient trust and regulatory compliance.

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Pharmaceutical Technology

JULY 21, 2022

The drug combination is anticipated to be made available in August and could only be used in compliance with the necessary conditions of the Swiss Society of Infectious Diseases (SSI). According to data from the PROVENT clinical trial, AZD7442 demonstrated a statistically significant decline in symptomatic Covid-19 development risk.

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Pharmaceutical Technology

DECEMBER 12, 2022

AMG-133, which has completed Phase I of development for obesity (NCT04478708), is of paramount interest as it is a first-in-class therapy for obesity. Clinical trial results in obese patients showed that by Day 85 of the study, participants in the multiple ascending doses (MAD) cohort showed a mean percentage change in body weight of -14.5%

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Pharmaceutical Technology

JUNE 14, 2023

Biologics form 51% of the current global drugs pipeline (highest stage of development as pipeline) according to GlobalData’s Drugs database (as of February 7, 2023). It is common for requirements to evolve and specifications to develop as the project unfolds.

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Pharma Marketing Network

JULY 13, 2023

Your website is your online storefront, so it’s important to choose the best web development company to create it. In the pharmaceutical industry, where trust and credibility are essential, it’s especially important to choose a web development company that understands the specific needs of your business. Trust your gut.

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pharmaphorum

SEPTEMBER 29, 2022

Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. If so, developers must develop and execute on a regulatory strategy. Food and Drug Administration (FDA) regulation as a medical device.

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pharmaphorum

JANUARY 6, 2023

Simplicity and technology intersect to streamline drug development. Jim Reilly, vice president, development cloud strategy, believes that “the intersection of operational simplification and technology advancement will create cross-functional efficiency across clinical, regulatory, quality, and safety.

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XTalks

DECEMBER 4, 2023

But today, with a rise in molecularly targeted therapies, oncology development has shifted to identifying an optimal biologic dose that balances toxicity with efficacy. Project Optimus is intended to reform the dose optimization and dose selection paradigm in oncology drug development,” says Dr. Confeld.

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XTalks

NOVEMBER 15, 2024

MDS are a group of blood disorders caused by abnormal development of blood cells in the bone marrow. This progression occurs when the abnormal cells in the bone marrow increase uncontrollably, leading to the development of a more aggressive form of blood cancer. “We

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