Agency IQ

OCTOBER 6, 2023

Under the 351(k) pathway, 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.

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FDA Biosimilars Science Drugs 52

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Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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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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Science FDA Clinical Trials Clinical Pharmacology 40

Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. Drug Hunter article, June 2023. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. Several metabolites were observed with an S -oxide and an acyl glucuronide being major human metabolites. Balazs et al.,

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Drugs Metabolic Stability FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. Drug Hunter article, June 2023. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. Several metabolites were observed with an S -oxide and an acyl glucuronide being major human metabolites. Balazs et al.,

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Metabolic Stability Drugs FDA Approval Treatment 52

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 Read AgencyIQ’s analysis of the draft guidance document here , and the two FDA-ASCO meetings here and here.]

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Science FDA Trials Clinical Pharmacology 40

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

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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FDA Science Regulations Production 40

Agency IQ

JUNE 2, 2023

Start Date End Date Event Event Type Center 06/05/2023 06/09/2023 Regulatory Education for Industry (REdI) Annual Conference 2023 Virtual CDER 06/07/2023 06/08/2023 Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development Public CDER 06/07/2023 06/08/2023 RDEA Pilot Program 2023 Public Workshop Workshop (..)

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FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

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. FDA is directed to issue new draft guidance or update existing guidance regarding Diversity Action Plans for clinical studies.

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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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Agency IQ

FEBRUARY 12, 2024

A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice. This is a topic that the agency has been keenly aware of for years, but it’s not clear from the title if it will refer to how the FDA will use A.I.

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Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

FEBRUARY 2, 2024

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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FDA Science Clinical Trials Regulations 40

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 Science Biosimilars Clinical Trials 40

Agency IQ

MARCH 1, 2024

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. FDA) FDA required to have resolved dispute with Vanda Pharmaceuticals or hold a hearing.

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FDA Science Clinical Trials Regulations 40

Agency IQ

DECEMBER 1, 2023

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. FDA is directed to issue new draft guidance or update existing guidance regarding Diversity Action Plans for clinical studies.

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Drug Target Review

JANUARY 20, 2025

These advances are reshaping how pharmaceutical and biotechnology companies approach clinical trial design, with a focus on patient-centric dosing strategies. This article explores how innovations in precision medicine are reshaping clinical trials, followed by a discussion on Project Optimus and its impact on dose optimisation.

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Clinical Trials Trials Drugs Drug Development 52

Drug Target Review

MARCH 25, 2025

Meet Luke Piggott Luke Piggott is Principal Scientist at Debiopharm, where he plays a key role in driving clinical and scientific research progress. With extensive experience in developing novel therapeutics, spanning discovery to clinical trials, he oversees both preclinical and clinical pharmacology of assets from Phase I to III.

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DNA Therapies Clinical Trials Clinical Pharmacology 52

Drug Target Review

NOVEMBER 27, 2024

This article highlights the benefits of leveraging advanced biomarker analysis methods, and how they ultimately save drug developers time and money by getting one step ahead of regulatory requirements. Clinical Pharmacology & Therapeutics. Outsourcing Biomarkers in Clinical Trials: Advantages and Disadvantages.

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