Drug Discovery World

NOVEMBER 25, 2022

Gene therapies have made the headlines over the last few days, with treatments for rare AADC deficiency, lung cancer and haemophilia B given the go ahead from regulators. Hope for drug that slows neurodegenerative disease . News round-up for 21-25 November by DDW Digital Content Editor Diana Spencer .

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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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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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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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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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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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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

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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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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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

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

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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Drug Discovery World

DECEMBER 8, 2023

Investments in AI and related technologies are driving this seismic shift where modest improvements in early-stage drug development success rates enabled by AI and machine learning could lead to an additional 50 novel therapies over 10 year s, a more than $50 billion opportunity.

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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

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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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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Drug Discovery World

JULY 11, 2023

How AI and ML are influencing drug development Biopharma has experienced significant growth in using these technologies for the past 10 years. However, other areas of the drug development pathway, such as target discovery, biomarker discovery, and product manufacturing, are increasingly looking to AI and ML to improve outcomes.

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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

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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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 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. Must also provide list of recommended documentation for AI contracts.

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Drug Discovery World

JANUARY 31, 2023

Savvy organisations anticipate these challenges early in the drug approval process. Biopharmaceutical Lifecycle Management (BPLM) is key to delivering novel therapies and lifesaving drugs to the world. Legacy processes often involve passing secure spreadsheets along with PDF documents like Certificate of Analysis.

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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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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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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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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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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) 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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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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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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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions.

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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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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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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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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 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. An updated Unified Agenda: The Unified Agenda is the U.S.

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Agency IQ

APRIL 19, 2024

These changes in the drug development landscape require novel clinical trial designs and innovative strategies for trial execution, an expanding range of drug development tools, and wider application in regulatory drug development of real-world data sources.” In particular, regulations in both the U.S.

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Agency IQ

DECEMBER 1, 2023

BY RACHEL COE, MSC | NOV 27, 2023 8:24 PM CST FDA’s transition away from public health emergency (PHE)-related guidance documents The Covid-19 Public Health Emergency (PHE) was activated on January 31, 2020. The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion.

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