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The “Smart” template the agency used to guide submission reviews — at the time of the OIG’s study — didn’t include any cybersecurity questions. Read More
Gottlieb said regulatory agencies and policymakers should take a consistent approach for all in vitro clinical tests regardless of whether they are developed by a traditional manufacturer or a clinical laboratory. Read More
FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren hailed the “reimagination” of health care delivery through mobile medical apps and cited steps the agency is taking to encourage innovations in the rapidly developing market. Read More
India’s Central Drugs Standard Control Organization is calling on Johnson & Johnson to compensate patients who suffered serious adverse events linked to the company’s ASR hip implants. Read More
NHS said the code will provide the basis for digital technology suppliers to enter into arrangements with technology companies and healthcare providers. Read More