Drug Patent Watch

DECEMBER 11, 2024

As the world grapples with the consequences of climate change, companies must adapt their operations to reduce environmental impacts while maintaining cost-effectiveness and regulatory compliance. Regulatory Compliance and Incentives Regulatory compliance is a critical aspect of sustainable generic drug development.

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FDA Law Blog: Biosimilars

JULY 22, 2024

The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M. s John W.M. s John W.M.

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DrugBank

SEPTEMBER 12, 2024

It enhances transparency by documenting the meaning, source, and context of each data point, which is crucial for maintaining compliance and making informed decisions about data usage. Not only is this best practice, it ensures we are always delivering you the highest integrity products.

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Drug Patent Watch

MARCH 17, 2025

That's why it's essential to develop a well-thought-out strategy that takes into account factors such as market research, regulatory compliance, and marketing tactics. Regulatory compliance : Ensuring that all necessary approvals and certifications are in place before launching the product.

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thought leadership

SEPTEMBER 23, 2024

Comprehensive Animal Health Medical Information (MI) and Pharmacovigilance (PV) support services in the veterinary industry are a must-have for companies who want to ensure the safety, efficacy, and quality of their animal health products.

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H1 Blog

NOVEMBER 15, 2023

How to Create an Effective KOL Engagement Plan That Complies with Anti-Kickback Laws In medical affairs, building and managing relationships with key opinion leaders (KOLs) is a critical component of successful product launches and long-term growth.

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Perficient: Drug Development

OCTOBER 9, 2024

Accessibility compliance in medical device software is more than a regulatory checkbox; it’s a strategic necessity that impacts user safety, market reach, and brand reputation. Partner with us to ensure your medical device software meets the highest standards of accessibility and compliance.

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PPD

DECEMBER 16, 2024

Addressing these underlying factors is essential; only by tackling the complexities of recruitment, timelines and regulatory compliance can sponsors achieve cost-effective and efficient trials, paving the way for long-term success in todays demanding market.

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Perficient: Drug Development

MARCH 26, 2024

Accessibility compliance is crucial to providing equal access to all users, including those with disabilities. Importance of Accessibility Compliance Accessibility compliance ensures that websites are usable by individuals with disabilities, such as vision impairments, mobility issues, or cognitive challenges.

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FDA Law Blog: Biosimilars

MARCH 21, 2024

Although much remains to be decided and industry is waiting for guidance from FDA related to some of these issues such as serious adverse event reporting, conference discussions all embraced the development of an appropriate internal company infrastructure to handle new requirements as part of a good faith display of compliance. By John W.M.

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Agency IQ

NOVEMBER 10, 2023

The FDA announced it intends to delay enforcement of cosmetic facility registration and cosmetic product listing requirements to July 1, 2024, from the current deadline of December 29, 2023 as required by Modernization of Cosmetics Regulation Act or MoCRA. Fill out the form to read the full article.

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Perficient: Drug Development

FEBRUARY 12, 2025

This transformation will require a delicate balance between innovation and compliance, ensuring that advancements in AI contribute to a secure and efficient payments landscape. These changes require significant adjustments in risk management, compliance frameworks, and operational protocols.

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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Drug Patent Watch

DECEMBER 12, 2024

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. Drugs requiring specialized equipment, complex formulations, or intricate production methods are less likely to face immediate generic competition.

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H1 Blog

NOVEMBER 21, 2023

However, before integrating an AI product into a life sciences workflow , it is crucial to evaluate its effectiveness and reliability rigorously. Therefore, a primary evaluation criterion should be the AI product’s ability to seamlessly integrate with the life sciences company’s data systems. How was the model trained?

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FDA Law Blog: Biosimilars

JULY 7, 2024

The first phaseout milestone is less than a year away; by May 6, 2025 most laboratories will need to demonstrate compliance with Medical Device Reporting (21 C.F.R. § Merely providing links to existing MDR training materials for traditional device manufacturers, as the new compliance guide does, fails to meet FDA’s stated objective.

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Perficient: Drug Development

JANUARY 6, 2025

At the heart of this transformation lies universal designa principle that advocates for the creation of environments and products to be usable by all people, to the greatest extent possible, without the need for adaptation or specialized design. The healthcare sector is witnessing an evolutionary shift towards inclusivity and accessibility.

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Tecan

DECEMBER 5, 2024

By David Keller Developing an effective product lifecycle management (LCM) process is no longer just a ‘nice to have’ for manufacturers in the medical and diagnostics equipment industry, but an essential ‘must have’ to ensure long-term business growth.

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Tecan

DECEMBER 5, 2024

By David Keller Developing an effective product lifecycle management (LCM) process is no longer just a ‘nice to have’ for manufacturers in the medical and diagnostics equipment industry, but an essential ‘must have’ to ensure long-term business growth.

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FDA Law Blog: Biosimilars

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. By John W.M.

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Perficient: Drug Development

AUGUST 4, 2024

Improved Security and Compliance With stringent regulatory requirements in the financial sector, security and compliance are paramount. Regulatory Reporting and Compliance Automation Compliance reporting is often a resource-intensive process.

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DS in Pharmatics

FEBRUARY 12, 2025

Cost estimation in drug product manufacturing is far from straightforward. Raw materials, labor, equipment, and quality and regulatory compliance all contribute to a complex web of expenses. Striking the right balance between operational efficiency and budget constraints poses a significant challenge for pharmaceutical companies.

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DS in Pharmatics

JUNE 12, 2024

Date: June 12, 2024 Location: San Diego, CA ProductLife Group (PLG), a leading provider of product development and compliance services in the pharmaceutical and biotechnological sectors, is excited to announce a comprehensive solution aimed at transforming the landscape of drug development, underscoring PLG's commitment to advancing healthcare through (..)

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Drug Patent Watch

DECEMBER 10, 2024

QMM involves the use of mathematical models to integrate scientific understanding and existing data about drug products, which can accelerate product development and regulatory assessment. Regulatory Compliance : Scientific experts must ensure that generic drug development adheres to strict regulatory guidelines. Cheung, K.

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Drug Patent Watch

FEBRUARY 26, 2025

To draft a strong patent application, you need to understand the nuances of biologic drug development, including the production process, stability, and formulation. Regulatory compliance : Biologics are subject to strict regulatory requirements, including those related to manufacturing, labeling, and marketing.

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FDA Law Blog: Biosimilars

DECEMBER 7, 2023

Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week. By Steven J. There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention.

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Advarra

AUGUST 8, 2024

We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. While some of the AI Act’s compliance dates are set for August 2024, the full Act will be enforced in March 2026.

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FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

While a DEA registration is not required to sell these products, by definition, any person selling these products is a “regulated person” and all sales of these products are considered “regulated transactions.” 21 U.S.C. § 21 U.S.C. §§ 802(38), (39)(B). It is unclear whether DEA had any conversations with eBay at that time.

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Perficient: Drug Development

AUGUST 12, 2024

AIS is designed to work natively with other Microsoft products and services such as Azure, Office 365, Dynamics 365, and Power Platform. Enhanced Security and Compliance Security and compliance are top priorities for any integration platform.

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thought leadership

SEPTEMBER 5, 2024

Securing a Premarket Approval (PMA) from the FDA is a significant achievement for any medical device manufacturer—a validation of your product's safety and effectiveness. But the journey doesn't end there.

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Perficient: Drug Development

SEPTEMBER 5, 2024

However, when it comes specifically to the management of your product data, it’s likely your ERP is lacking in some key capabilities and not providing you with everything your organization really needs. Sure, your ERP most likely stores some general product information like a unique Identifier, or some sort of SKU.

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PPD

JULY 16, 2024

Our recent white paper explores the many ways in which a functional service provider (FSP) engagement delivers key pharmacovigilance (PV) capabilities necessary across the product life span and across different geographical regions. The client initially had eight Investigational Medicinal Products (IMPs) and around 60 active protocols.

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Drug Patent Watch

DECEMBER 30, 2024

Manufacturing and Quality Control : The PMDA evaluates the manufacturing process and quality control measures of the generic drug to ensure compliance with Japanese regulatory standards. Pharmaceutical companies must navigate the PMDA’s requirements and guidelines to ensure successful approval and marketing of their products.

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Perficient: Drug Development

JULY 28, 2023

In today’s business landscape, enterprises are constantly seeking ways to improve employee productivity, engagement, and well-being. By providing valuable data-driven insights, Viva Insights enables enterprises to make informed decisions that foster a more productive and thriving work environment.

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thought leadership

MAY 10, 2024

In January 2024, the FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products issued a guidance document- Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.

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Alta Sciences

JULY 18, 2024

Inside The Altascientist: How to Achieve Optimal Preclinical Formulation and Drug Product Manufacture aasimakopoulos Thu, 07/18/2024 - 20:33 Formulating and manufacturing drugs for preclinical testing is an early—and necessary—step towards pushing your molecule through to human clinical trials.

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Alta Sciences

NOVEMBER 4, 2024

The Challenge: Safe Manufacture of Highly Potent APIs Exposure to highly potent APIs must be carefully managed during production. Known to be a reproductive toxin and harmful to aquatic life, it required careful containment measures during production.

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