3874 Result Found

Nov. 1, 2021
Raps
Nitrosamine detection t…

Pharmaceutical manufacturers should ensure that the analytical tests they are using are “fit for purpose” to ensur…

Nov. 1, 2021
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FDA official: Growing n…

Many of the US Food and Drug Administration’s (FDA) drug good manufacturing practice (GMP) warning letters and imp…

Nov. 1, 2021
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FDA issued vaccine EUAs…

Manufacturers of COVID-19 vaccines currently authorized for emergency use did not undergo facility inspections bef…

Oct. 29, 2021
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FDA launches portal for…

The US Food and Drug Administration (FDA) on Friday launched its new NextGen Portal for reporting manufacturing vo…

Oct. 29, 2021
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FDA authorizes Pfizer C…

The first US emergency use authorization (EUA) for younger children to receive a COVID-19 vaccine has been issued,…

Oct. 29, 2021
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Improving transparency …

Over the last decade, the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Health Canada…

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The US Food and Drug Administration (FDA) has released draft guidance for industry that outlines the agency’s thin…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

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