FDA Warning Wire: Online Eye Exam Gets Agency Side-Eye
Law360 (March 13, 2018, 6:47 PM EDT) -- The U.S. Food and Drug Administration looked askance at a company's marketing of an online eye exam without the agency's go-ahead, found problems at an Indian drugmaker's plant in Malaysia and scolded a Korean X-ray maker for not reporting accidental radiation exposures.
Here's this week's roundup of the agency's enforcement actions:
FDA Side-Eyes Online Eye Exam
The FDA did not look charitably on a Chicago-based company's marketing of an eye exam mobile app without first getting the agency's permission.
The agency told Opternative Inc. that it doesn’t have an approved application for premarket approval or an approved application for an investigational...
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