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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 …

Oct. 19, 2021
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EMA shares lessons lear…

The lack of mature quality data, such as sufficient batch data, hindered the ability of the European Medicines Age…

Oct. 18, 2021
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Cyltezo approved as int…

An anti-inflammatory biosimilar from Boehringer-Ingelheim has received interchangeability designation from the US …

Oct. 18, 2021
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EC updates Clinical Tri…

The European Commission has issued an updated question-and-answer clarifying certain aspects of the Clinical Trial…

Oct. 15, 2021
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FDA officials tout prog…

The US Food and Drug Administration’s (FDA’S) efforts to encourage the industry’s adoption of advanced manufacturi…

Oct. 15, 2021
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FDA adcomm unanimous on…

The vaccines advisory committee of the US Food and Drug Administration (FDA) voted unanimously Friday to recommend…

Oct. 15, 2021
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CHMP recommends 6 medic…

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) this week recommended …

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