FDA Law Blog: Biosimilars

AUGUST 23, 2023

By the end of Q2 FY 2023, FDA will convene the first of a series of 5 public meetings or workshops with key stakeholders including patients, biopharmaceutical companies, DHT companies, and academia to gather input into issues related to the use of DHTs in regulatory decision-making.

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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

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. Read AgencyIQ’s analysis of a lower court’s ruling.

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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

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. This class-wide issue been an ongoing point of discussion both in the U.S.

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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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Drug Discovery World

SEPTEMBER 5, 2022

Throughout the continuum of drug development, from target discovery to patient selection, machine learning approaches are being adopted to reliably mine vast amounts of data and make predictions with higher accuracy Anita Ramanathan discusses how machine learning is currently used across different stages of cancer research. .

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Perficient: Drug Development

JUNE 13, 2024

Education and Training: Integrating accessibility and inclusive design into educational curricula for designers, developers, and engineers can build a foundation for future professionals. Offering workshops, certifications, and continuous learning opportunities can keep professionals updated on best practices and emerging trends.

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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

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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Agency IQ

JULY 28, 2023

FAR regulations require contracting officers to “promote and provide for full and open competition in soliciting offers and awarding Government contracts.” The FDA’s Project Optimus is focused on these issues, which have been explored in a series of meetings , workshops, and FDA advisory committee meetings.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The workshop is also discussed in Cell & Gene here and here.

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The Pharma Data

JANUARY 16, 2021

molecular assessment within two weeks after receiving plasmids, to advance R&D process for antibody drug development. With its sophisticated quality and service systems, JS Bio will accelerate the application of Etta Biotech’s products in antibody drug development in the industry.

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Drug Discovery World

MARCH 14, 2023

The drug development process requires collaboration at all stages, and is particularly important in the rare disease setting, where in addition to pharmaceutical industry stakeholders, patients and patient advocacy groups play a central role. However, the market still has room for growth.

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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.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 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

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. FDORA also directed the FDA to convene a meeting.

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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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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 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

JANUARY 19, 2024

The work could represent early steps toward modernizing one part of FDA’s regulation of this complicated product class. BY AMANDA CONTI | JAN 16, 2024 7:43 PM CST Regulatory background: complex generics Unlike new drug products, generic drugs do not require extensive clinical evidence to demonstrate safety or efficacy.

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Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. EMA has now published a report on the workshop; read on for AgencyIQ’s analysis.

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Agency IQ

FEBRUARY 2, 2024

The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996. The document has been updated over time to implement advances in understanding cancer and drug development. In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance.

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Agency IQ

DECEMBER 11, 2023

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more.

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Agency IQ

AUGUST 2, 2024

Department of Commerce, was directed to take the lead on much of the cross-Department work under the AI EO in 2023, including framing underlying frameworks/guidance on developing, using and overseeing AI that can be used across the federal government.

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Agency IQ

JULY 28, 2023

October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

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