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Oct. 26, 2021
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Asia-Pacific Roundup: T…

Australia's Therapeutic Goods Administration (TGA) is seeking feedback on plans to make it mandatory for healthcar…

Oct. 25, 2021
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FDA encourages industry…

An official with the US Food and Drug Administration (FDA) encouraged the pharmaceutical industry to adopt advance…

Oct. 25, 2021
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ICH stakeholders contem…

The International Council for Harmonisation (ICH) has issued a 30th anniversary publication that reflects on its h…

Oct. 22, 2021
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FDA drafts data standar…

The US Food and Drug Administration (FDA) has released draft guidance for industry that outlines the agency’s thin…

Oct. 22, 2021
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Europe’s MDCG offers gu…

A new guidance document from the European Commission’s Medical Device Coordination Group (MDCG) spells out how the…

Oct. 20, 2021
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FDA Approvals Roundup: …

Oyster Point’s Tyrvaya (varenicline solution nasal spray) has been for treating dry eye disease. Approval for Tyrv…

Oct. 20, 2021
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Consent decree shuts do…

A Utah-based manufacturer and seller of herbal remedies and nutritional supplements has agreed not to market or se…

Oct. 20, 2021
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FDA shows jump in compe…

The US Food and Drug Administration (FDA) approved a steadily increasing number of competitive generic therapy (CG…

Oct. 20, 2021
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FDA okays Moderna, J&J,…

The US Food and Drug Administration has authorized booster doses of both the Moderna COVID-19 vaccine and the vacc…

Oct. 19, 2021
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FDA says IRB review sti…

The US Food and Drug Administration (FDA) reiterates that clinical studies of diagnostic devices (IVDs) using left…

Oct. 19, 2021
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FDA issues proposed OTC…

The US Food and Drug Administration (FDA) has issued a long-awaited proposed rule to create a new regulatory categ…

Oct. 19, 2021
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Asia-Pacific Roundup: T…

Australia’s Therapeutic Goods Administration (TGA) is set to allow more flexibility in how medical device patient …

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