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PharmaTher Announces Assigned FDA Approval Goal Date of its Priority Original Abbreviated New Drug Application for Ketamine

PharmaTher Announces Assigned FDA Approval Goal Date of its Priority Original Abbreviated New Drug Application for Ketamine
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PharmaTher Provides Update of its Priority Original Abbreviated New Drug Application for Ketamine

TORONTO, April 18, 2024 PharmaTher Holdings Ltd. , a specialty pharmaceutical company, today announced receipt of a Complete Response Letter for its Priority Original Abbreviated New Drug.

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Inhalation Sciences Sweden : to present at FDA's public workshop GDUFA on May 20th, 2024 -April 10, 2024 at 02:33 am EDT

Inhalation Sciences to present at FDA s public workshop GDUFA on May 20th, 2024 Inhalation Sciences Sweden AB has been invited to provide a public comments presentation at the.

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FDA Science, Research, and Collaboration Advance Generic Medicines

In 2023, GDUFA-funded research helped expand our understanding of generic drug products, including complex products, and contributed to the development of advanced methods to characterize product quality and performance.

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Getting Generic Drugs Right FDA Revises ANDA Guidance

Getting Generic Drugs Right FDA Revises ANDA Guidance
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