Regulatory Focus

FDA Guidance For Inhalants

Applications for nasal sprays and inhalants must meet criteria in FDA document.

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CR Protocol for Nonreclosables

European standard beefs up child-resistance testing of nonreclosable packages.

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Electronic Labeling Submissions

FDA cites speed and accuracy as benefits of electronic submissions for labeling.

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Label Claims for Supplements

FDA helps companies determine acceptable claims for nutritional supplements.

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New Guidance on Geriatric Labeling

Manufacturers now have a tool clarifying a 1997 rule on labeling statements regarding geriatric use of drugs and biologics.

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Centrally Filled Controlled Substances

Rule will help retail pharmacies, which regularly offload work central-fill pharmacies because of pharmacist shortage.

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CR Packaging for OTC Switches

Agency aims to protect children from the entire OTC product.

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Survival of the Fittest Drug Label

Several FDA initiatives are aiming to make prescription-drug labeling more clear, informative, accessible, and consistent.

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FDA Revisits Reprocessed Device Issue

The agency's new draft guidance clarifies issues related to premarket submissions for reprocessed single-use medical devices.

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FDA Puts a Leash on Stability Testing

The agency has finalized a guidance on stability testing of new, particulary sensitive veterinary medicines.

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