On June 2, 2023, drug manufacturer Shire US Inc. and related entity Shire LLC (collectively, “Shire”) asked the Supreme Court to review an Eleventh Circuit ruling involving the interplay between state ...
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) ...
Project Renewal updates older oncology drug labels to ensure clinical relevance and scientific accuracy, involving external experts and early-career scientists. Fludarabine phosphate's updated label ...
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Drug labelling norms under review: Expiry date readability flagged; govt panel to examine packaging reforms
India’s top drug regulator has set up a sub-committee to revamp labelling norms on medicinal products after receiving consumer complaints about illegible expiry dates and glossy packaging that hampers ...
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