Agency IQ

DECEMBER 11, 2023

So far, the key takeaway was that both industry and regulators are still identifying best practices on setting enrollment targets in their research plans. A big concern for researchers, IRBs and regulators: Diversity beyond race and ethnicity. And this should be done before pen is put to paper to write a clinical study protocol.”Fashoyin-Aje

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Agency IQ

DECEMBER 1, 2023

The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion. Over the course of the PHE—which spanned more than three years—the FDA used its expanded authority extensively to issue new direct-to-final guidance documents, creating over 80 in total.

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The Pharma Data

DECEMBER 21, 2020

As UNITY reported in its press release, this “Phase I, first-in-human, open-label, single-ascending dose study being conducted by UNITY is designed to evaluate the safety, tolerability, and pharmacokinetics of UBX1325 in patients with advanced DME. Forward-Looking Statements.

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PPD

JUNE 20, 2023

The staff transfer team at the PPD clinical research business of Thermo Fisher Scientific provides transfer success rates that average nearly 90% for FSP engagements and are experts in Acquired Rights Directive laws and regulations. Go deeper with our experts on rebadging advantages and best practices in this Applied Clinical Trials article.

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The Anticancer Fund

JUNE 7, 2022

Being listed is no endorsement of the results and conclusions of the article. All articles need to be critically assessed and viewed in their broader research context. This pharmacokinetic study (n=9) compared half-dose erlotinib (75 mg/day) with the HIV drug ritonavir (200 mg/day) with full-dose erlotinib (150 mg/day).

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Codon

APRIL 2, 2023

This is Codon Digest, a weekly roundup of research papers, news articles, and industry highlights about engineered biology. Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals. Thanks for skimming. ❤️ Subscribe to support human writers. Ricciardi M.J. Science Translational Medicine.

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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. For a more complete discussion of endpoints in oncology clinical trials, see this recent AgencyIQ article.

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Agency IQ

JUNE 9, 2023

Products included in this category are those which “directly stimulate signaling in an immune cell subtype or indirectly enhance the immune system response by blocking or activating an endogenous regulator of the immune system response.” CBER-regulated products are no longer within scope of the guidance.

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Agency IQ

AUGUST 9, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. What about combination products?

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Agency IQ

FEBRUARY 23, 2024

. … And I do think it’s really important to go as high up as we can safely, because there are issues that have already been mentioned – inter-tumor heterogeneity, issues of tumor penetration and [pharmacokinetics] PK.”

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Agency IQ

SEPTEMBER 22, 2023

In 1972, when regulatory authority for biologic products was transferred from the National Institutes of Health (NIH) to the FDA, the agency extended the two-study framework to biologic regulation as well. We also expect that some of these confirmatory evidence types will be used far more sparingly than others.

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

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The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. The review under Article 5(3) was separate, but ran in parallel to the rolling review of casirivimab and imdevimab, which is currently ongoing by the EMA. About the Japanese Special Approval for Emergency.

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The committee also made recommendations regarding pharmacokinetic and safety assessments.

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Agency IQ

FEBRUARY 23, 2024

That passage is referred to as pharmacokinetics (PK) and incorporates four important phases – absorption, distribution, metabolism, and excretion (ADME). To date, regulators have offered little in the way of guidance to sponsors developing drugs for patients with obesity Currently, the U.S.

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The Pharma Data

MARCH 5, 2021

The CHMP scientific opinion under Article 5.3 of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. Lilly Antibody Therapies Around the World.

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The Pharma Data

MAY 7, 2021

GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19. Sotrovimab is also under review by other global regulators including Health Canada under the expedited Interim Order application pathway for COVID-19 drugs. Review will support a formal Marketing Authorisation Application.

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Agency IQ

AUGUST 16, 2024

Today, though, patients, clinicians, and regulators expect more. Just a few months after the draft guidance on dose optimization was published, a handful of OCE staff, including its leaders, published a landmark article in March 2023.

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Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

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Advarra

DECEMBER 14, 2022

Safety, quality of life, and pharmacokinetic (PK) responses are not considered to be therapeutic objectives. These assessments are supported by Medicare-approved guidelines and/or journal articles. The trial is in compliance with Federal regulations relating to the protection of human subjects. Indications.

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Agency IQ

JUNE 28, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. ANNA ESHOO (D-Calif.)

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