Regulatory Affairs

Altaire Gets 483 for Mold in Eye Drop Drugs

The FDA chided OTC drugmaker Altaire for an inadequate response to numerous customer complaints of mold in the eye drop product carboxymethylcellulose sodium 0.5 percent ophthalmic solution, 30 mL. Read More

FDA Considers Safety Exceptions to Salt Drug Labeling Policy

Sponsors of drugs with salt-based active ingredients are urged to follow the United States Pharmacopeia’s (USP) strict naming rules for such drugs, but the FDA may make an exception when the name of the salt contains “vital information” for clinical use, new draft guidance states. Read More

$100M Settlement Deal in Sight for NECC Victims

Negotiators overseeing a civil suit related to last year’s nationwide outbreak of fungal meningitis say they have reached a tentative settlement with the Massachusetts compounder linked to the outbreak that could see victims and creditors receive more than $100 million. Read More