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The video “fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety,” the agency said. Read More
The implants are made using additive manufacturing, with a porous surface structure that enables in-growth and bone attachment to the implant. Read More
The new requirements address labeling, shelf life and temperature requirements as well as general requirements for registering devices and IVDs in Saudi Arabia. Read More
Roche executives said the FDA based the priority review decision on clinical trials that showed it decreases symptom duration and viral shedding. The drug is already approved for use in Japan. Read More