Agency IQ

SEPTEMBER 15, 2023

The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. 25 mg)” — such doses had been suggested in the Citizen Petition.

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Agency IQ

DECEMBER 11, 2023

So far in 2023, the Office has co-authored fifteen guidance documents—the majority of which were drafts—offering insight into the agency’s thinking on several key policy issues, such as clinical trial diversity and the accelerated approval pathway. These issues are especially apparent in treatments that are intended for chronic use.

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The Anticancer Fund

JUNE 7, 2022

Please get in touch if you’re interested in discussing research based on the findings presented below ( info@anticancerfund.org ). This is another study that is strongly supportive of replication and further development, including clinical trial development.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. Interestingly, minor (<10% of total drug related materials) metabolites present in human plasma at steady state including one defluorinated and eight oxidised metabolites. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION.

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Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. Interestingly, minor (<10% of total drug related materials) metabolites present in human plasma at steady state including one defluorinated and eight oxidised metabolites. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION.

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Agency IQ

FEBRUARY 23, 2024

On the first day, discussants looked at how to tackle first-in human trials, weighed the importance of the maximum tolerated dose, and looked at the evolving concept of the clinical utility index. Read AgencyIQ’s analysis of the draft guidance document here , and the two FDA-ASCO meetings here and here.]

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Agency IQ

OCTOBER 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process.

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Agency IQ

SEPTEMBER 29, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Agency IQ

JUNE 2, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Agency IQ

OCTOBER 27, 2023

Government shutdown: At present, the U.S. 12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. federal government has appropriated funding through November 17.

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Agency IQ

JULY 8, 2024

Start Date End Date Event Event Type Center 07/10/2024 07/10/2024 Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method Webcast CDRH 07/10/2024 07/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Exploring Religious Literacy and Spirituality in Cancer Care” Webcast (..)

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Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. 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.

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Agency IQ

FEBRUARY 2, 2024

Government shutdown: At present, the FDA has appropriated funding March 1. EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.

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Agency IQ

MARCH 1, 2024

Government shutdown: At present, the FDA has appropriated funding lasting until midnight on Friday, March 1. District Court March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.

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Agency IQ

DECEMBER 1, 2023

Government shutdown: At present, the FDA has appropriated funding through January 19. 12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs.

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Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

raw scores, standardized norm-referenced scores), some of which might present floor or ceiling effects; and ensuring that selected COAs have demonstrated reliability across demographic groups. Considering that, the safety data generated during clinical trials may not capture all possible delayed adverse events.”

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Drug Target Review

NOVEMBER 27, 2024

Finally, its application in urine samples presents additional challenges compared to serum. Clinical Pharmacology & Therapeutics. Outsourcing Biomarkers in Clinical Trials: Advantages and Disadvantages. 2022 Mar 5;112(1):69–80. Handbook of Biomarkers and Precision Medicine, pp. Chapman and Hall/CRC, 2019.

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