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FDA Raising Civil Money Penalties for Inflation

[ Price : $8.95]

FDA issues a direct final rule to adjust for inflation the maximum civil money penalty amounts it can impose.

Info on Condom Labeling Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on a Class 2 special controls guidance on labeling for nat...

Ethex Recalls 5 Generics

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Ethex recalls specific lots of five generic drugs that may contain oversized tablets.

Review Period Set for Ixempra

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Federal Register Notice: FDA determines the regulatory review period for patent extension for Bristol-Myers Squibbs Ixempra.

Review Period Set for Tykerb

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Federal Register Notice: FDA determines the regulatory review period for GlaxoSmithKlines Tykerb for the purpose of patent extensi...

Special Controls Guidance for Latex Condoms

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Federal Register Final rule: FDA designates a guidance document to serve as a special control for natural rubber latex condom.

Automated Drug Labs! Lets Think Outside the Box

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Consulting editor John Scharmann proposes a different solution to tainted imports automated drug labs that would save the cost of...

FDA Surfaxin Response Review Target Set for April

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FDA accepts for review a Discovery Labs complete response to a May approvable letter for Surfaxin (lucinactant), indicated for pre...

FDA Issues Condom Special Controls Guidance

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FDA issues a guidance accompanying reclassification of latex condoms to Class II special controls.

Onsolis Risk Management Meeting Set

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FDA sets a risk mitigation meeting with BioDelivery Sciences for its Onsolis pain treatment.