JD Supra

Shire v. Blackburn: Drawing the Line Between FDA Drug Labeling Regulations and State Law on Product Liability

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 ...
JD Supra

FDA proposes mandatory patient labeling for Rx drugs - Proposed Patient Medication Information (PMI) is the latest in many efforts by FDA to mandate patient-directed labeling

Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the agency’s prescription drug ...
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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 ...