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Leveraging Online FDA Information to Accelerate ANDA Timelines

thought leadership

Delays in Abbreviated New Drug Application (ANDA) submissions or setbacks during FDA review can mean missed market opportunities, especially in competitive therapeutic areas.

FDA
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Future-proofing drug development with GenAI

Drug Target Review

New approach methodologies data In April, the US Food and Drug Administration (FDA) announced a plan to replace animal testing in the development of monoclonal antibodies and other therapies with validated “human-relevant” methods, including AI-based computational models evaluating toxicity, cellular lines and organoid toxicity.

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The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. FDA has already been there , of course, with respect to 180-day exclusivity.)

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Leadership in the Age of Stacks

LifeSciVC

Introduction At this year’s Guggenheim biotech investor conference in Boston, the keynote wasn’t about drug pipelines, IPO windows, or FDA guidance. As the landscape becomes more layered, infrastructural, and globally entangled, the kinds of organizations we build and the leadership they require may need to evolve in response.

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Nixing the Newborn Screening Advisory Committee Is Ill-Advised

PLOS: DNA Science

The RUSP is not part of FDA. Kefalas tells her story in her compelling book Harnessing Grief: A Mother’s Quest for Meaning and Miracles. The List RUSP is a state-by-state roster of up to 61 “actionable” metabolic conditions. But it must begin ASAP.

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Levers for Biological Progress

Codon

Today, a single injection of an FDA-approved gene therapy, called Hemgenix , cures this disease. I’m currently reading Gene Dreams , a book published in 1989 by Robert Teitelman. I’m considering turning these ideas into a full-length book and would appreciate your insights. Cite: Niko McCarty.

DNA
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Panel urges FDA to remove warnings on hormonal menopause therapy

BioPharma Drive: Drug Pricing

Led by FDA Commissioner Martin Makary, the meeting focused on the benefits and risks of menopause hormone therapy, or MHT, which has become a controversial topic due to mixed study data. The meeting Thursday did not set aside time for public participation, but a docket for comments will be open on the Federal Register, an FDA official said.