Cytel

JUNE 2, 2023

Data submissions are very regulated, but every drug and drug development are different. Therefore, the data presented in the Common Technical Document (CTD) needs to be tailored to the specific submission.

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PPD

OCTOBER 17, 2024

This expansion represents a significant opportunity for both drug developers and patients, while also presenting a new and diverse set of challenges for drug developers, particularly in clinical trial execution. They also need to have the medical competencies to manage adverse events often associated with these therapies.

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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.

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DNA Regulations Drug Development Disease 105

Fierce BioTech

OCTOBER 26, 2023

Efficient clinical pharmacology review of a marketing application requires early and thoughtful consideration of the development plan, timely conduct of necessary clinical studies, maximizing available clinical data using model-informed drug development (MIDD) approaches, and expert communication of integrated information.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Regulations FDA 52

Pharmaceutical Development Group

DECEMBER 19, 2021

Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services , expedite a FDA Pre-Submission Review, and lead to FDA Approval. Author Information William E. Spanogle, Ph.D.

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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors.

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Clinical Trials Trials FDA Regulations 105

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. IND, CTA, NDA, BLA). “If

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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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Perficient: Drug Development

NOVEMBER 6, 2023

The Internal ChatGPT proof of concept was developed on Azure’s OpenAI chat interface. It enables employees to retrieve information from various documents and databases within a company’s internal network. This eliminates the need for manual searches through multiple documents, saving valuable time for employees.

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International Regulations Production 64

Conversations in Drug Development Trends

NOVEMBER 12, 2024

The process, from patient coordination through manufacturing and administration, is intricate, time-sensitive, and highly regulated. There are also nuances for operational planning in cell therapy development programs. Operationalizing these trials requires proactive and flawless management at every stage.

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Therapies Clinical Supply Clinical Trials Molecular Biology 72

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. This is what OIRA is currently reviewing.

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Perficient: Drug Development

DECEMBER 1, 2023

Immediately following the Silicon Valley Bank (SVB) failure, Perficient’s Financial Services Risk Management and Regulatory Capabilities Center of Excellence (CoE) swiftly analyzed publicly available documents, providing readers with a comprehensive breakdown of the bank’s failure.

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Regulations Compliance 52

Advarra

DECEMBER 14, 2023

Sites working with an investigational new drug (IND) are often subject to an FDA site inspection. Through the inspection, any potential violations of the FDA’s requirements are documented in a Form FDA 483 as observations, also called findings or citations. Documents should be well named and always up to date on the current version.

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Compliance FDA Clinical Trials Trials 52

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

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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. Harmonizing regulatory requirements and complying with all relevant regulations are crucial for the success of adaptive MRCTs.

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Trials Clinical Trials Regulations FDA 80

Perficient: Drug Development

FEBRUARY 15, 2024

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence The announcement of significant amendments to the New York State Department of Financial Services (NYSDFS) regulations on December 1, 2023, represents a pivotal moment for entities operating within New York’s financial sector.

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Compliance Regulations Licensing Licensing 52

Perficient: Drug Development

FEBRUARY 15, 2024

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence Perficient’s Risk and Regulatory Center of Excellence (CoE) remains at the forefront of evolving financial rules and regulations, ensuring readiness to tackle emerging challenges and safeguard financial institutions and its customers.

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Compliance Licensing Licensing Regulations 52

Perficient: Drug Development

OCTOBER 15, 2024

Lets talk about data governance in banking and financial services, one area I have loved working in and in various areas of it … where data isn’t just data, numbers aren’t just numbers … They’re sacred artifacts that need to be protected, documented, and, of course, regulated within an inch of their lives.

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Perficient: Drug Development

SEPTEMBER 11, 2023

Already reviewed by Perficient, BES provides a secure and efficient portal to exchange documents, information, and communications for consumer compliance and Community Reinvestment Act (CRA) examinations. By the time people started speaking of Y2K , regulators were accepting documents from the bank prior to starting the onsite examination.

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Compliance Regulations 52

The Premier Consulting Blog

JUNE 26, 2023

1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Food and Drug Administration. Guidance Document: Expedited Programs for Serious Conditions —Drugs and Biologics.

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Perficient: Drug Development

JULY 25, 2024

Two million documents will be lost by the IRS each year if 99.9% Risk, regulation, and legal compliance , for instance, need to be near perfect. But with more scrutiny around regulations, they’ve stopped saying that. Not Perfect Enough That’s not to say we shouldn’t ever strive to be better. Of course we should! is good enough.

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Alta Sciences

AUGUST 21, 2024

Internships at Altasciences: Q&A With Our Summer Interns nbartlett Thu, 08/22/2024 - 04:44 Internships at Altasciences are more than just a stepping stone—they’re a gateway to real-world-experience and professional growth, giving the next generation opportunities to help shape progress in the drug development industry.

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International Laboratories Science Molecular Biology 40

Agency IQ

JUNE 26, 2023

Today, the FDA unveiled a contract notice that explains the process for how it will develop that report, obtain public input, and deliver the report’s final recommendations. a disease or condition is defined as rare by the Orphan Drug Act (ODA) if it affects fewer than 200,000 people. regulators. In the U.S., Recently, U.S.

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FDA Disease Regulations Production 40

Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

JULY 12, 2024

FDA gives companies leeway to go after misinformation, but not free reign In a new revised draft guidance document, the FDA says it will allow life sciences companies to address misinformation about their products that is posted online. In regulation, intended use is defined at 21 CFR 201.128 for drugs and 21 CFR 801.4

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FDA Regulations Production Science 40

FDA Law Blog: Biosimilars

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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Production Clinical Trials FDA Drugs 52

Perficient: Drug Development

JANUARY 16, 2024

Regularly review and update policies annually to ensure compliance with current rules and regulations. Implement a check and balance or send policies/procedures through a multi-business review approach to confirm documentation updates and adherence to current rules and regulations.

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Compliance Regulations International Production 52

Perficient: Drug Development

AUGUST 17, 2023

Of course, this recycling creates a need for regulations and compliance to ensure tracking of battery history, transfer of ownership, and regulations for different regions. What Can OEMs Do to Manage Changing Battery Regulations?

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Compliance Regulations Production International 52

Agency IQ

MAY 10, 2024

What life sciences companies need to know about NIST’s new AI guidance The National Institute of Standards and Technology (NIST) last week released four new documents on artificial intelligence, mostly focusing on generative AI (GAI). development, deployment, real-world monitoring). Number three: Dangerous or violent recommendations.

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Science FDA Production Regulations 40

Perficient: Drug Development

NOVEMBER 7, 2023

Agile is a set of principles and practices for project management and product development that emphasizes flexibility, collaboration, customer-centricity, and adaptability to change. For healthcare entities, this change is intensified by stringent regulations, intricate procedures, and the vital importance of patient care and member services.

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Pharmaceutical Development Group

JANUARY 5, 2022

Compliance with these new focus points hinge upon proactive utilization Drug Development Services , effective FDA Pre-Submission, and comprehensive Regulatory Consulting. Collectively leveraged, this will focus on the FDA’s vital points and lead to FDA Drug Approval. Author Information William E. Spanogle, Ph.D.

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Production FDA Regulations Science 52

The Pharma Data

FEBRUARY 13, 2022

This guidance may further spur development of these types of non-addictive treatment options to reduce the footprint of opioid use in this setting. The SUPPORT Act directs the agency to issue or update existing guidance to help address challenges to developing non-addictive medical products to manage pain. Source link: [link].

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FDA Treatment Drug Development Production 40

Advarra

JUNE 28, 2022

Failure to Have a Pre-Investigational New Drug (IND) Meeting. There are a myriad of regulations coming into play during the drug development process. Because of this, the FDA understands sponsors may need help making sense of regulations. One such meeting is the pre-IND meeting.

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FDA Regulations Clinical Trials Packaging 52

Perficient: Drug Development

JUNE 13, 2024

Compliance: Many industries have strict data privacy regulations. Verifying accessibility helps maintain compliance with these regulations. Compliance: Maintain adherence to industry regulations. Benefits Recap: Data Security: Prevent unauthorized data access and protect sensitive information. Happy coding!

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Compliance Regulations 52

FDA Law Blog: Drug Discovery

JANUARY 7, 2024

A PMR is a study “that sponsors are required to conduct under one or more statutes or regulations,” whereas a PMC is a study “that a sponsor has agreed to conduct, but that are not required by a statute or regulation” (see FDA Webpage, Postmarketing Requirements and Commitments: Introduction ).

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The Premier Consulting Blog

MARCH 13, 2023

For researchers who are developing or working with analytical procedures, the new ICH Q14 Analytical Procedure Development and revised ICH Q2(R2) Validation of Analytical Procedures drafts represent foundational guidance documents. Read Part 2 here.)

International 52

International Production Regulations Drugs 52

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. FDA is also due to revise 24 other guidance documents at that time.

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