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FDA Raising Civil Money Penalties for Inflation

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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...

Teva Loses Bid for Early Launch on Generic Prevacid

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The U.S. Court of Appeals for the Federal Circuit affirms a lower court ruling against a Teva bid to launch a generic copy of TAP'...

Nidek, Doctors et al Sued for FDA-unapproved Lasik

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A California lawyer files a federal class action suit against Japan-based ophthalmic laser maker Nidek, physicians and surgical fa...