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Manufacturers should provide better information about specific risks and directions for use of hydrogen peroxide-based contact lens care products (HPCPs), the FDA said in a draft guidance released yesterday. Read More
Although a quality agreement is not specifically required or defined in FDA regulations, the FDA may ask during an inspection to review any documents that describe the way you manage contract service providers. Read More
The FDA has published a landmark final rule that creates a new category of over-the-counter (OTC) hearing aids aimed at improving access and lowering the cost of the devices. Read More
Becton Dickinson will co-market Accelerate Diagnostics’ rapid tests for antibiotic resistance and susceptibility under an agreement the companies announced yesterday. Read More