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The FDA is finalizing guidance that urges sponsors to minimize device design changes in generic drug delivery products, and outlines how differences could threaten substitutability. Read More
India’s regulation of marketing practices for devices currently falls under the broader Uniform Code for Pharma Marketing Practices, which was introduced in 2011. Read More
The House Energy and Commerce Committee is giving the Department of Health and Human Services until no later than Dec. 15 to come up with an action plan for creating “bills of materials” to enhance cybersecurity for healthcare technologies. Read More
The lawmakers pointed to recent cyber attacks that highlighted the vulnerabilities and unpreparedness of the healthcare sector to “increasingly sophisticated and rapidly evolving cyber threats.” Read More
NPPA issued the new memorandum after it received a request from Abbott Healthcare to withdraw its coronary stents from the market because of “commercial unviability.” Read More
The FDA is taking a three-tiered approach to next-generation sequencing oncology with a newly approved tumor profiling assay, the accreditation of the New York Department of Health as an FDA third-party reviewer, and the creation of the Class II regulatory pathway for these devices. Read More