Government Regulations and Their Effect on the Drug Sector

Government regulations affect drug development, often prolonging the process, but they ensure safety and efficacy to protect ...
JD Supra

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) ...
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 ...
chronicleonline.comOpinion

FDA’s labeling overhaul threatens to accelerate pharmacy closures

America is in the midst of a pharmacy crisis, and the Food and Drug Administration could make it much worse. Hundreds of ...
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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 ...