U.S. Food and Drug Administration News

The U.S. Food and Drug Administration (FDA) released a list of regulations that it expects to publish in 2015. These forthcoming regulations include rules on medical device labels and package inserts, over the counter (OTC) drugs, equivalence reports, radiology devices, requirements for foreign and domestic establishment registration, good manufacturing practice (GMP) for outsourcing facilities and medical device clinical trials.

Expected in December 2014, the FDA has delayed publishing a new generic labeling rule until September 2015. The rule would let generic drug manufacturers update their labeling with new safety information before the FDA reviews the change.

While some new requirements under the Drug Supply Chain Security Act (DSCA) came into effect in November 2014, many begin in 2015. The rules apply to manufacturers, wholesale distributors, dispensers, repackagers and logistics providers. The new requirements include reporting licensure, providing product tracing information, handling suspicious products and confirming authorized trading partners. Additional draft guidance has recently been released on these topics.

The FDA issued a final guidance recommending that manufacturers of passive implanted medical devices test and label their devices for compatibility with magnetic resonance imaging (MRI) scans. Other new guidance provides recommendations for submitting proposed manufacturing changes for already approved drugs. The FDA also announced proposed changes to adverse event reporting forms. Another proposed rule would require prescribing information for doctors to be distributed electronically.