Advarra

JUNE 12, 2023

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. What do the Regulations Say about IBC Review? What Does an IBC Review?

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FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

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FDA Law Blog: Biosimilars

FEBRUARY 19, 2024

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. During her FDA tenure, Ms. Gibbs , HP&M Director.

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Perficient: Drug Development

NOVEMBER 21, 2024

The first compliance deadline of April 1, 2026, impacts the largest organizations. The compliance deadline, however, depends on the firm’s total receipts from calendar years 2023 and 2024. Compliance deadlines follow a staggered rollout based on total assets. The ruling demands action from all non-depository firms (e.g.,

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Drug Patent Watch

DECEMBER 10, 2024

These agencies set guidelines and regulations that generic drug manufacturers must follow to ensure that their products are bioequivalent to the innovator drug. Regulatory agencies also conduct inspections and audits to ensure compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) guidelines.

Drug Development 52

Drug Development Compliance Drugs Regulations 52

Perficient: Drug Development

NOVEMBER 15, 2024

election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. Strict regulations around HIPAA, PHI, and PII create significant barriers, making it difficult to adopt off-the-shelf AI solutions from fields like commerce or digital experience.

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Regulations Compliance Production Nurses 64

Perficient: Drug Development

JUNE 3, 2025

Compliance : Helps organizations meet regulatory and compliance requirements by providing detailed logging and monitoring capabilities. Azure Firewall helps organizations meet these regulatory and compliance requirements by providing detailed logging and monitoring capabilities.

Compliance 52

Compliance Engineering Government Regulations 52

Perficient: Drug Development

JANUARY 16, 2024

a healthcare and life sciences software engineering firm based in San Diego, California, with European operations located in Cluj-Napoca, Romania. We’re a full-service software engineering service provider focused on improving the patient experience through innovative software solutions and technologies.

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Engineering Science Compliance Production 64

DrugBank

JUNE 13, 2024

These microscopic particles, which are smaller than 100 nanometers, can be engineered to deliver drugs to specific targets with precision. Viral vectors, engineered from modified viruses that have lost their disease-causing potential, have emerged as a powerful tool for this purpose.

Therapies 98

Therapies Drugs DNA Treatment 98

Perficient: Drug Development

NOVEMBER 15, 2024

election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. Strict regulations around HIPAA, PHI, and PII create significant barriers, making it difficult to adopt off-the-shelf AI solutions from fields like commerce or digital experience.

Regulations 52

Regulations Compliance Production Nurses 52

Perficient: Drug Development

APRIL 18, 2024

Of course, providing this “new and improved” service will require re-writing front ends and processing engines to provide the necessary data in a timely manner. Traditionally, banks hoarded financial data, sharing it sparingly on a need-to-know basis.

Regulations 52

Regulations Compliance Engineering 52

FDA Law Blog: Biosimilars

DECEMBER 6, 2023

filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.

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Laboratories FDA Regulations Compliance 59

ACTO

SEPTEMBER 26, 2023

According to a study by Growth Engineering, personalized learning programs can boost engagement by up to 60% compared to traditional one-size-fits-all training approaches. Improved Knowledge Retention Retention of knowledge is crucial for field representatives who need to stay current with ever-evolving products and changing regulations.

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Compliance Pharmaceuticals Pharmaceutical Companies Engineering 52

DrugBank

JULY 8, 2024

This membrane regulates the diffusion of the drug from the reservoir into the skin. Nanoparticles offer a versatile platform for drug delivery, where their size and surface properties can be engineered to optimize interaction with the skin. Encapsulating drugs within nanoparticles brings several advantages for TDD.

Treatment 98

Treatment Drugs Clinical Trials Engineering 98

Alta Sciences

MARCH 8, 2024

Thousands of HPAPIs are currently in development that promise lower dose requirements, enhanced efficacy, improved patient compliance, and fewer side effects. Listen or read Issue 35 of The Altascientist on altasciences.com , or wherever you listen to podcasts: WHAT DEFINES HIGH POTENCY FOR AN API?

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Compliance Engineering Regulations Drug Development 52

Drug Target Review

AUGUST 9, 2024

3 Patient compliance is a critical but complex challenge, with contributing factors reaching beyond just drug formulation. But there are considerations that can be taken in drug formulation to improve patient compliance and therefore lead to better health outcomes. Engineering precision nanoparticles for drug delivery.

Science 59

Science Drugs Compliance Drug Development 59

Perficient: Drug Development

JUNE 13, 2024

Education: Educational programs in design and engineering may not adequately cover accessibility and inclusive design principles, leaving professionals underprepared to implement them. Ensuring compliance with multiple standards across different regions and industries adds to the complexity.

Engineering 52

Engineering Compliance Government Regulations 52

Perficient: Drug Development

APRIL 25, 2025

These solutions support healthcare provider transformation initiatives, helpdesk management, network monitoring, and compliance with healthcare IT regulations.

Marketing 52

Marketing Compliance Engineering Regulations 52

The Premier Consulting Blog

NOVEMBER 12, 2023

“Artificial Intelligence (AI) and Machine Learning (ML) as a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as learning, making decisions, and making predictions. Contact us today to find out how we can support your program.

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FDA Drug Development Regulations FDA Approval 52

Drug Target Review

DECEMBER 5, 2024

2,3 Engineering both the capsid and DNA cargo improves the safety and efficacy of rAAV vectors and expands their clinical applications. As a result, there is a need for validated AAV testing solutions to meet quality standards as well as compliance and regulatory requirements. References Pratt CB, Alsarraj MA. Labcompare.

Therapies 52

Therapies Virus DNA Compliance 52

Perficient: Drug Development

JUNE 25, 2024

Learning from history, he referenced the lack of regulatory controls in derivatives and financial engineering before the 2008 financial crisis, and more recently, the unregulated growth of cryptocurrencies leading to the “Crypto Winter” of 2022.

Regulations 52

Regulations Engineering Marketing Compliance 52

Vial

MAY 15, 2024

Headquartered in San Francisco, California, the rapidly growing company is supported by a robust team of nearly 200 employees, all of whom combine expertise ranging from clinical trial management and medicine to software engineering and product development.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Vial

MAY 1, 2024

The team at Vial is a blend of ClinOps (Clinical Operations) expertise and software product and engineering expertise, who have worked together to develop Vial’s technology platform and raise over $100M. The funds have enabled the company to successfully become a leading global, full-service CRO reshaping the future of clinical trials.

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Clinical Trials Trials Compliance Engineering 52

The Pharma Data

MAY 3, 2021

Many in the regulatory profession have transitioned from an established previous career such as engineering, law, or bench research. Articles during May will focus on the EU Medical Devices Regulation and In Vitro Diagnostic Regulation. Continuous professional development. And June?

Production 52

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Agency IQ

NOVEMBER 3, 2023

The proposal includes varied compliance timeframes, phaseouts, time-limited exemptions, and workplace controls for certain uses. OCT 30, 2023 6:28 PM CDT TCE and regulation under TSCA Trichloroethylene also known as TCE (CAS RN 79-01-6) is a volatile organic compound used mostly in industrial and commercial processes.

Compliance 40

Compliance Treatment Engineering Production 40

Perficient: Drug Development

MAY 16, 2024

Legal Obligations : Many countries have laws and regulations mandating accessibility standards for digital content and technology. Observing GAAD raises awareness about these legal obligations and encourages compliance to ensure equal access and prevent discrimination.

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Production Marketing Compliance Engineering 52

Vial

FEBRUARY 23, 2024

A number of factors are contributing to this increase in popularity of digital patient portals, including the surge in telemedicine needs following the COVID-19 pandemic, technological advances enabling better integration of mobile-based health platforms, as well as federal regulations shifting to accommodate remote data accessibility.

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Advarra

NOVEMBER 29, 2022

However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines. Taken together, these initiatives offer more frequent interactions between sponsors and regulators to communicate and discuss technological advances.

Therapies 52

Therapies Clinical Trials FDA Production 52

Agency IQ

JUNE 7, 2024

The regulations would come into effect 12 months after publication of the final rule for manufacturers, 15 months for processors, 18 months for distributing to retailers, 21 months for all other distributors, and 24 months for industrial and commercial users. The EPA proposed a tiered phase-out period for prohibitions.

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Compliance Production Engineering Regulations 40

Advarra

OCTOBER 26, 2023

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. Even if the environment is familiar, with or without hazards, the unknown or unlikely is a biosafety consideration.

Production 52

Production Pharmacy Clinical Trials Engineering 52

Agency IQ

SEPTEMBER 29, 2023

Regulators wanted input on questions related to data access and re-use, to inform its legislative framework on common European data spaces. Two intertwined proposals have been laid out – a regulation on data governance and the proposed data act. Data intermediation service is defined in Regulation (EU) 2022/868.

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Regulations Government Production International 40

Agency IQ

MARCH 7, 2024

As stated by the FDA , the proposed HFP will allow the agency to truly fulfill the vision laid out in the FSMA, “elevate the importance of nutrition to help reduce diet-related diseases,” and leverage existing partnerships and new technologies so as to “more effectively regulate and uphold safety of the nation’s food supply.”

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The Pharma Data

JULY 27, 2021

“Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. chief executive officer of Teneobio.

Production 52

Production Clinical Trials Government Disease 52

Agency IQ

JUNE 17, 2024

These are the lists of national and international standards the Commission plans to harmonize with its device and diagnostics regulations. But standards harmonized under the directives may not be used to show compliance with the new Medical Device Regulation, which replaced the MDD. This is similar to the situation in the U.S.,

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Agency IQ

MARCH 25, 2024

This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes. Now, the proposed list is out, and its limited length may be a surprise to stakeholders. BY CHELSEY MCINTYRE, PHARMD | MAR 20, 2024 10:32 PM CDT Background: Drug compounding in the U.S.

FDA 40

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Perficient: Drug Development

AUGUST 17, 2023

The ripple effect will be essential as EV penetration continues to rise in the United States, although it also opens a whole new area of regulatory compliance with batteries which was not as big of a factor when EV penetration was much lower. What Can OEMs Do to Manage Changing Battery Regulations?

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Compliance Regulations Production International 52

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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