Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. New Drug Application (NDA) : Needed for marketing approval of new drugs. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs.

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Drug Development Clinical Pharmacology Pharmaceutical Companies Pharmaceutical Companies 52

Putting Patients First Blog

SEPTEMBER 26, 2024

Further discussion on the unique aspects of rare disease drug development, the associated challenges, and when waivers may be warranted would greatly benefit all stakeholders, including sponsors, patient organizations, clinical researchers, and regulators. Clinical Pharmacology & Therapeutics , 97(3) , 263–273.

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Communication Clinical Pharmacology Documentation Drug Development 52

FDA Law Blog: Biosimilars

OCTOBER 28, 2024

This Guidance explicitly excludes gene therapies (a change from the draft guidance), but instead makes reference to a separate guidance that has been in place since 2020 titled Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.

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Clinical Pharmacology Communication Drug Development 64