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The device industry’s two most prominent associations are threatening to take legislative action to curtail excessive user fees imposed on medical devices.
The FDA revealed last week that it is forming an intercenter group to focus explicitly on medical product advertising and other promotional activities.
The FDA last week discreetly extended the deadline for single-use device (SUD) reprocessors to submit additional validation data that prove their reprocessed products are substantially equivalent to the original device.
The final monograph for OTC nasal-decongestant drug products will be amended to remove the indication “for the temporary relief of nasal congestion associated with sinusitis” and to prohibit use of the terms “sinusitis” and “associated sinusitis” elsewhere in the labeling, under an FDA proposal.
The FDA has given its approval to GlaxoSmithKline (GSK) and Gilead Sciences for the first once-a-day fixed-dose combination (FDC) AIDS drugs, which will treat AIDS patients in the U.S. and in developing countries.
The FDA plans to implement a series of recommendations within the next six months on best management practices relating to the agency’s drug review process.
The federal government, through an inter- agency task force established in January, is developing a set of enforcement procedures that will provide various agencies with uniform, and it hopes, effective strategies to halt illicit drug importation.
The FDA is in the early stages of developing a new guidance on how a genetic testing device could be co-developed with a drug or biologic to create a new combination product.