Agency IQ

AUGUST 9, 2024

FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far Last month, the FDA published a new draft guidance document on diversity action plans. The section of the guidance on enrollment goals begins on page 11 of the document. Read AgencyIQ’s extensive analysis of the draft guidance here.]

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Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

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The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. A similar draft guidance document for drug development is in process. 1 Among the topics highlighted is the “model-informed drug development (MIDD) initiative.”

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The Pharma Data

JULY 29, 2021

Gilead presented additional lenacapavir clinical development program data at the International AIDS Society (“IAS”) 2021 Conference on HIV Science. Kite announced a purchase agreement with BioNTech SE to acquire Kite’s solid tumor neoantigen T cell receptor R&D platform and clinical manufacturing facility in Gaithersburg, Maryland.

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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PPD

JULY 11, 2023

To move patient diversity forward, our experts recommend a multi-dimensional lens to understand how the intersectionality of characteristics plays a role in diversifying clinical trials. Patient diversity in clinical research requires a multi-faceted approach. Document and track reasons for screen failure.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

For drugs, the rationale should describe data and information, if any, that suggest the potential for differential safety and effectiveness across the clinically relevant population, such as possible differences in PK or PD. 510(k) submission, De Novo classification request, Premarket Approval (“PMA”) application).

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The Pharma Data

APRIL 4, 2023

Forty-seven percent of patients had a documented baseline HbA1c of <5.7%. Merck has the industry’s largest immuno-oncology clinical research program. Forty-five percent of patients had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 1 and 15% had an ECOG performance status of 2.

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Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. That said, FDA has not done nothing in 2024 related to clinical trial diversity.

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