Agency IQ

JULY 7, 2023

This study was developed to help establish a workable framework for using real-world evidence (RWE) for regulatory cases within the E.U., building off the EMA’s Strategy through 2025. Regulators have been investing in ways to understand better how RWE can be used and how RWD is generated.

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Regulations Research Production Government 40

Perficient: Drug Development

OCTOBER 7, 2024

Introduction A quick summary of the new official digital sign requirement of the FDIC is that effective January 1, 2025, this logo: must be replaced by this logo: For readers who missed part 1 of this series or want to reread the original blog can find it here. 12 CFR § 328.5(a).

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Compliance Regulations Research 52

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

JULY 28, 2023

FAR regulations require contracting officers to “promote and provide for full and open competition in soliciting offers and awarding Government contracts.” Industry wants its products reviewed quickly, efficiently and predictably. Without sufficient resources, the FDA is unable to do so.

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Perficient: Drug Development

NOVEMBER 14, 2023

My son’s part of Generation Alpha, a cohort that includes children born between 2010 and 2025. And games like Mightier combine biofeedback with emotional regulation to teach kids how to control their anger and anxiety. That’s where you as a healthcare marketer come in. The oldest of the Gen Alpha kids are only 13.

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Agency IQ

JULY 22, 2024

The regulators were off to a slow start, with just three total approvals in the first two months of 2024. Assuming that the comment period is not extended, and FDA meets its statutory timeline to finalize the guidance within nine months of the closing of the comment period, the guidance could theoretically be put into force by late 2025.

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Agency IQ

JUNE 21, 2024

Modeled on the Operation Warp Speed vaccine development communications approach, the pilot aims to test out a rapid communications approach for accelerating rare disease drug development. Marks also conceded that certain gene therapies might also have a different acceptable approach for confirmatory studies.

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Disease Science FDA Production 40

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 study is planned to start in late 2024 and conclude in late 2025.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. Another question is the impact on rare disease drug development, where broader populations are small and there may be limited knowledge about differential impacts of disease. 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).

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Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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Agency IQ

FEBRUARY 2, 2024

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S.,

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FDA Laboratories Regulations Production 40

Agency IQ

JULY 22, 2024

While the agency has been working to implement its rule, which has broad-reaching impacts for diagnostics and drug developers, other moves by the Supreme Court and legislators could impact the agency’s next steps. AgencyIQ provides a status update for regulated industry. diagnostic products are regulated as medical devices.

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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. Although the E.U.

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Clinical Trials Regulations Trials FDA 40

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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Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Discover how drug developers, researchers, and regulators are ensuring this happens. Tags Clinical Trials Weight 15

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Agency IQ

JUNE 28, 2024

In response, regulators reiterated its importance and prioritization without committing to a specific time frame for publication. That statutory requirement for a DAP is based on the applicability of the Investigational Device Regulations (IDE). ANNA ESHOO (D-Calif.) at a Friends of Cancer Research event in February 2024.

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