ACTO

DECEMBER 17, 2024

Such cross-functional collaboration ensures consistent implementation from drug development through commercialization. The Foundational Pillars ACTO believes in implementing four foundational pillars that will ensure responsible AI solutions that address pharmas highly regulated parameters, while providing value.

Government 52

Government Compliance Pharmaceutical Companies Pharmaceuticals 52

Perficient: Drug Development

JANUARY 6, 2025

Universal design (UD) in healthcare ensures that facilities, services, and information are accessible to everyone, regardless of their physical abilities. This approach encompasses architectural designs, patient communication methods, and even the format of health information.

Compliance 52

Compliance Regulations Treatment Production 52

The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

Perficient: Drug Development

APRIL 22, 2024

Let’s explore why understanding perceptible information is crucial for creating accessible pedestrian crossings and how it contributes to universal design principles. Perceptible information, such as clear signage, audible signals, and tactile indicators, helps pedestrians navigate crossings safely and confidently.

Compliance 52

Compliance Regulations 52

Perficient: Drug Development

AUGUST 19, 2024

The vision is that all of the data can be aggregated, harmonized and used for better, faster and more informed decision making for Financial and Non Financial Risk Management. where’s my Insight”) The primary goal of data management, sourcing and aggregation effort will have to be converting data into informational insights.

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Regulations Marketing Government Compliance 109

Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey. Be prepared to share necessary information about your study with the CRO,” says Chad.

Drug Development 52

Drug Development Clinical Trials Trials Drugs 52

Drug Patent Watch

JANUARY 9, 2025

Navigating the complex landscape of drug development and manufacturing can be a daunting task. Enter the Contract Development and Manufacturing Organization (CDMO) a lifeline for many startups looking to bring their innovative therapies to market. Staying ahead of trends can help you make more informed decisions.

Compliance 52

Compliance Drug Development Therapies Pharma Companies 52

NIH Director's Blog: Drug Development

APRIL 2, 2020

With so much information swirling around these days about the coronavirus disease 2019 (COVID-19) pandemic, it would be easy to miss one of the most interesting and significant basic science reports of the past few weeks. The protein is known to play a prominent role in the body’s complex system of regulating blood pressure.

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Drug Development Drugs Science Medical Schools 52

FDA Law Blog: Biosimilars

APRIL 2, 2024

Under the heading “Facilitating Competition” are multiple initiatives designed to either hasten development of generic drugs or limit blockades to market. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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FDA Biosimilars Production Marketing 104

KIF1A

JANUARY 13, 2024

This process is regulated so we end up with the right number of neurons, which we can imagine with some simplified math: If you start with one progenitor and need eight neurons, it isn’t efficient for that progenitor to make a single neuron eight times.

DNA 105

DNA Regulations Drug Development Disease 105

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. E-mail: regs.comments@occ.treas.gov.

Regulations 52

Regulations Compliance 52

Drug Target Review

JULY 4, 2023

1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. Antibody drug conjugated with cytotoxic payload. antibody linked to a biologically active cytotoxic (anticancer) payload or drug 3d rendering. Cancer Cell [Internet].

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Small Molecule Drugs Clinical Pharmacology Trials 145

Advarra

AUGUST 10, 2023

Given the relatively small populations affected by any one rare disease or condition, a pharmaceutical company developing an orphan drug may reasonably expect the final approved drug to generate relatively small sales (when compared with the drug development costs) and consequently incur a financial loss.

Drug Development 52

Drug Development Disease Therapies Engineering 52

FDA Law Blog: Drug Discovery

JANUARY 30, 2025

Conducting with Due Diligence: How Sponsors Attend to the Resources, Monitor Progress, & Modify Study Designs to Complete Confirmatory Trials on Time FDAs authority to require confirmatory trials for a drug approved via accelerated approval have long included the ability to withdraw the drug for failure to conduct such trials with due diligence.

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FDA Trials Disease Drugs 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.

Regulations 52

Regulations Compliance International Science 52

FDA Law Blog: Drug Discovery

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ).

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Therapies Trials FDA Clinical Trials 98

Perficient: Drug Development

NOVEMBER 14, 2023

Data privacy has become an increasingly complex subject, especially with the introduction of the California Consumer Privacy Act (CCPA) and similar regulations emerging in other states. Non-compliance with these regulations can result in hefty fines, as seen with Sephora’s recent $1.2

Compliance 98

Compliance Regulations Production Marketing 98

Perficient: Drug Development

FEBRUARY 29, 2024

Geo-coding data with tags to comply with European regulations is also a possible target of opportunity. Compliance and Regulation This is related to, and can be used in conjunction with, data classification and security. In an increasing regulated data environment, it pays to make your data assets easy to regulate.

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Government Regulations Compliance Marketing 78

PPD

FEBRUARY 10, 2025

Sponsors find that an FSP solution is often the best choice to help advance their drug development projects, whether they need to fill small gaps in services or support large-scale programs with dedicated teams across functions. EMRs give clinical operations teams direct, remote access to an array of patient health information.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. FDA notes that the distinctions between responsibilities for these groups and DMCs should be clearly defined, particularly with respect to access to unblinded information.

Clinical Trials 105

Clinical Trials Trials FDA Regulations 105

Perficient: Drug Development

JULY 28, 2023

By providing valuable data-driven insights, Viva Insights enables enterprises to make informed decisions that foster a more productive and thriving work environment. By analyzing trends and patterns, enterprises can make informed decisions to optimize workflows, identify areas of improvement, and support their workforce effectively.

Compliance 97

Compliance Production Regulations 97

Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. However, building that scalable process with minimal batch variability is a challenge.

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Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

FDA Law Blog: Drug Discovery

MARCH 6, 2024

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. More information about the conference can be found here. S for reduced registration fees.

FDA 59

FDA Compliance Pharmaceuticals Pharmaceutical Companies 59

Fierce BioTech

OCTOBER 26, 2023

Eva Gil Berglund, PhD Justin Hay, PhD Paola Coppola, MSc Duration 60 Minutes Clinical pharmacology information comprises more than 50% of a drug label. Inadequate clinical pharmacology development programs can cause sponsors to have significant issues during the review period or impact the approvability of their marketing applications.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Regulations Marketing 52

Perficient: Drug Development

MARCH 6, 2024

However, full adherence to HHS guidance and HIPAA regulations is non-negotiable, so in light of recent guidance, change is completely warranted. With the Salesforce Marketing Cloud Personalization suite, marketers can keep up wit h evolving regulations and consumers’ growing demand for privacy, while building loyalty through personalization.

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Marketing Regulations Compliance Science 122

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

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Therapies FDA FDA Approval Treatment 119

Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA. Our mission is a lofty one.

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FDA Trials Clinical Trials Disease 96

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. Drug developers must consider ways to remove these barriers to enhance their ability to recruit and retain trial participants.

Trials 69

Trials Clinical Trials Drug Development Therapies 69

Perficient: Drug Development

JANUARY 24, 2024

Before I begin, I just want to caveat everything with the fact that HIPAA is a complex regulation open to interpretation, and in the end your legal and compliance teams need to be comfortable with how you handle data and the risk associated with those methods. The other part of the definition is what constitutes “health information.”

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Licensing Licensing Production Regulations 96

H1 Blog

SEPTEMBER 26, 2023

Data Sharing Beyond Borders One of the most difficult aspects is sharing data between countries – especially when it comes to patient health information , which must remain secure while navigating a variety of different laws. From legal considerations to data privacy regulations, the challenges facing these teams can be daunting.

Trials 59

Trials Clinical Trials International Regulations 59

The Premier Consulting Blog

NOVEMBER 12, 2023

This feedback prompted the FDA to release a second paper in 2021 titled “ Artificial Intelligence/Machine Learning (AI.ML)-Based Software as a Medical Device (SaMD) Action Plan ,” which outlined the agency’s five-pillar approach to regulating AI/ML.

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FDA Drug Development Regulations FDA Approval 52

Conversations in Drug Development Trends

AUGUST 9, 2024

Managing this complexity highlights the importance of global communication plans and constant communication with global regulators and keeping all required documentation up to date. Additionally, keeping sites, principal investigators (PIs), and patients informed of changes and updates can present challenges.

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Trials Clinical Trials Regulations FDA 80

DrugBank

OCTOBER 4, 2024

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. Recent changes in drug approval processes, intellectual property laws, and pricing regulations have introduced both opportunities and challenges for dealmakers.

Pharmaceuticals 80

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 80

ACTO

DECEMBER 17, 2024

Such cross-functional collaboration ensures consistent implementation from drug development through commercialization. The Foundational Pillars ACTO believes in implementing four foundational pillars that will ensure responsible AI solutions that address pharmas highly regulated parameters, while providing value.

Government 52

Government Compliance Pharmaceutical Companies Pharmaceuticals 52

Perficient: Drug Development

NOVEMBER 6, 2023

It enables employees to retrieve information from various documents and databases within a company’s internal network. Whether it’s HR policies, industry-specific regulations, sales history, or other use cases, the chatbot can be trained to provide accurate and relevant information based on your business needs.

International 64

International Regulations Production 64

The Pharma Data

SEPTEMBER 9, 2020

We respect your privacy, by clicking “Download Your Copy” you will receive our e-newsletter, including information on Podcasts, Webinars, event discounts, online learning opportunities and agree to our User Agreement. For further information on how we process and monitor your personal data click here.

Production 52

Production Laboratories Compliance Government 52

The Pharma Data

MAY 17, 2021

The Accelerating COVID-19 Therapeutics Interventions and Vaccines (ACTIV) public-private initiative coordinated by the Foundation for the National Institutes of Health is one excellent example of master protocols being used to simultaneously study a number of promising drugs. Additional Information. Today, the U.S.

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FDA Treatment Clinical Trials Trials 52