The Pharma Data

NOVEMBER 24, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

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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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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 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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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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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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Advarra

AUGUST 21, 2024

Nowhere is this more painful than in clinical trials, the backbone of drug development. These complex studies typically generate hundreds or thousands of documents to share across clinical trial sites, pharmaceutical sponsors, physicians, patients, and regulators.

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FDA Law Blog: Drug Discovery

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

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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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Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in helping companies overcome these regulatory hurdles.

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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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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.

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Perficient: Drug Development

OCTOBER 28, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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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 21, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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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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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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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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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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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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Perficient: Drug Development

NOVEMBER 8, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility. Documentation and validation.

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Regulations Compliance Government International 52

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

Perficient: Drug Development

NOVEMBER 4, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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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 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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FDA Law Blog: Drug Discovery

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. the Confirmatory Evidence Guidance, available here ) had appeared on CDER’s Guidance Agenda for the past three years.

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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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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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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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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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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.

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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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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 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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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.)

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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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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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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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