Putting Patients First Blog

APRIL 7, 2025

NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics (PDF) April 7, 2025 Dockets Management Staff U.S. 9 AI can significantly enhance drug discovery by analyzing vast datasets to detect patterns often missed by traditional approaches, thus accelerating early-stage development.

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PharmaTech

JUNE 6, 2025

Image source: ©huiying - stock.adobe.com Biopharmaceutical product development is burgeoning with developments in treatment approaches, chemistries, and vectors giving companies new strategies for targeting disease. Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1).

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Putting Patients First Blog

APRIL 14, 2023

Driven by the work of the Food and Drug Administration on patient-focused drug development (PFDD), many companies in the biopharmaceutical community have devoted significant resources to better understand patient populations and are working to bring to market products that best suit their needs. Sincerely, Randall L.

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FDA Law Blog: Biosimilars

JUNE 9, 2025

In 2016—dubbed the “Year of Clinical Trials Diversity” by FDA—the agency published two guidance documents in furtherance of FDASIA related to the standardized collection and reporting of race and ethnicity data in submissions of drug and device clinical trials (see our previous blog post on the device guidance here ).

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FDA Law Blog: Biosimilars

JULY 9, 2024

Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents. For drugs, the relevant CDER/CBER Division may or may not provide feedback; sponsors with specific questions may include them as a topic for discussion in meetings with FDA.

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FDA Law Blog: Biosimilars

JANUARY 30, 2025

To this end, the December 2024 draft guidance and a companion guidance published January 7, 2025, Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway (the January 2025 draft guidance ) describe FDAs latest thinking on what it means to conduct a confirmatory trial with due diligence.

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Putting Patients First Blog

FEBRUARY 19, 2025

NHCs Patient Experience Data Assets: Evidence-based tools to improve patient health outcomes February 19, 2025 By: Omar A. Join the NHC for the 2025 Science of Patient Engagement Symposium on May 78. Interested in learning more about how engaging patients can drive innovation in medicine, MedTech, and AI? Registration opens on Feb.

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National Association of Boards of Pharmacy

APRIL 23, 2025

The NAPLEX Content Outline will take effect for NAPLEX exams administered on or after May 1, 2025. As is typical with a practice analysis, some new content areas which are important to contemporary entry-level pharmacy practice were identified in the content outline development. Whats In the Content Outline? 25% (50 questions) 2.

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BioPharma Dive

JUNE 5, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from FDA’s AI tool ‘Elsa’ is here, and the industry has questions The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool’s rollout.

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