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

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

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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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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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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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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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

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

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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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

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

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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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

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

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

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

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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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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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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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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The Premier Consulting Blog

FEBRUARY 11, 2025

Identifying a safe and effective dose for registrational trials is one of the most critical and complex aspects of early-stage drug development for rare diseases. Traditionally, early drug development focuses on ensuring the safety of clinical doses, with regulatory authorities prioritizing patient protection.

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The Premier Consulting Blog

OCTOBER 30, 2024

To support this, the Innovative Technologies and Advanced Manufacturing Hub (I-TEAM Hub) was created. As outlined earlier in this blog, innovative manufacturing techniques are key for producing superior quality medicine, as improvement in quality manufacturing can limit drug shortages due to quality-related issues.

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Drug Channels

FEBRUARY 3, 2025

Informa Connect's Access USA March 18-20, 2025, Pre-Event Workshops on March 17 Drug Channels readers save 10%* on their registration with code 25AUSA10 Three events. Rare Disease Summit Download Agenda While the industry has seen heightened focus surrounding rare drug development, weve only scratched the surface.

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The Premier Consulting Blog

JANUARY 14, 2025

Offers fellowship programs and workshops, on-demand learning, and lecture series. Rare Cancers Program An initiative for development of new products to treat rare cancers Leverage multiple OCE projects and initiatives that address the challenges of developing new treatments for cancers that affect a small number of patients.

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Perficient: Drug Development

MARCH 8, 2025

This transformation might involve establishing paid consulting opportunities for community experts, creating accessible design workshops in underserved neighborhoods, or forming equitable partnerships where decision-making authority is genuinely shared.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents. CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc.

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