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The FDA has issued a draft guidance to help manufacturers prepare 510(k)s following the reclassification of absorbable hemostatic devices as Class II special controls.
The FDA Oct. 24 issued an updated draft guidance on portable blood glucose monitoring systems (BGMS) with recommendations on topics from risk management to performance evaluation.
The FDA recently issued Q&A guidance to help regulated firms determine how to better understand and meet the agency’s requirements for certain human drug and biologic products to have bar codes with a minimum of a National Drug Code number.
The FDA is planning to update its combination products regulations because the intercenter agreements governing how combination and single-entity products are assigned to FDA centers have become "incomplete statements," the agency said.
The FDA is prepared to “move swiftly” to approve applications for fixed-dose combinations of previously approved drugs to treat HIV, saying it expects to be able to expedite priority reviews and approve fast track designations for such products.
In an effort to help biological product manufacturers report deviations from current good manufacturing practices (cGMPs), the FDA issued a guidance detailing the correct steps to take when an event occurs that may affect the safety, purity or potency of products.
The FDA is prepared to "move swiftly" to approve applications for fixed-dose combinations of previously approved drugs to treat HIV, saying it expects to be able to expedite priority reviews and approve fast track designations for such products.
The U.S. Food and Drug Administration (FDA) issued a new guidance Sept. 28 to help makers of cell-based viral vaccines improve the development and availability of vaccines, including those to address emerging and pandemic threats.
The U.S. Food and Drug Administration (FDA) is seeking to help the pharma industry adopt modern quality management system principles so that companies can produce drugs more efficiently, lower costs and prevent shortages through a new guidance released Sept. 29.