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Single-Arm Trials Using Real-World Evidence for Rare Disease Product Development

Camargo

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. Natural history data becomes critical for product development when there is no concurrent control.

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Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 1

Camargo

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. As of January 1, 2021 , EU pharmaceutical regulations do not apply to the United Kingdom, which formally left the EU in January 2020.

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PDUFA VII: More Changes Coming in the Latest Reauthorization

Camargo

As we noted in a separate blog post , the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases. Receipt of Background Package. Response Time. calendar days).

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Animals Need Drugs Too, But Not Without CVM Approval

FDA Law Blog

Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

Drugs 59
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Can technology help diversify clinical trials?

pharmaphorum

As the shift to home working proliferated during the pandemic, work became decentralised – and many businesses were able to be productive with a workforce at home. You can read part one of this article here. Teams and Zoom became the backbone of communication and firms embraced new ways of working. About the interviewees.

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The Regulatory Binder Checklist For Clinical Trial Sites

Advarra

Protocol and amendments Purpose: To document revisions of trial-related documents during the trial Documents: Log of protocol changes, IRB-approved protocol with principal investigator (PI) signature page, IRB-approved case report forms, IRB-approved advertisements and participant information sheets, protocol amendments Informed consent documents Purpose: (..)

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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog

This product was developed by uniQure prior to being licensed to CSL Behring. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.