Applications for nasal sprays and inhalants must meet criteria in FDA document.
European standard beefs up child-resistance testing of nonreclosable packages.
FDA cites speed and accuracy as benefits of electronic submissions for labeling.
FDA helps companies determine acceptable claims for nutritional supplements.
Manufacturers now have a tool clarifying a 1997 rule on labeling statements regarding geriatric use of drugs and biologics.
Rule will help retail pharmacies, which regularly offload work central-fill pharmacies because of pharmacist shortage.
Several FDA initiatives are aiming to make prescription-drug labeling more clear, informative, accessible, and consistent.
The agency's new draft guidance clarifies issues related to premarket submissions for reprocessed single-use medical devices.
The agency has finalized a guidance on stability testing of new, particulary sensitive veterinary medicines.