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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: No Long-term Studies on Remoxys Tamper Resistance

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FDA reviewers say Pain Therapeutics did not conduct long-term studies to determine whether its proposed abuse-resistant formulatio...

Obama Could Increase Off-label Enforcement

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Attorney and ex-FDAer Marc Scheineson says drug companies fear that the incoming Obama administration may step up enforcement of o...

Branded Company May Be Liable for Generic Adverse Events

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A California appeals court says a failure-to-warn suit brought against Wyeth by someone claiming injuries from a generic form of a...

FDA Funding Boosters Merge

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The two external constituency organizations lobbying for higher congressional appropriations for FDA decide to merge as the Coalit...

FDA Issues Two Draft Harmonized Guidances

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FDA issues draft harmonized guidances as annexes to the evaluation and recommendation of pharmacopeial texts.

Advisors Want More OTC Decongestant Studies

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Members of two FDA advisory committees say there is some evidence that phenylephrine is an effective decongestant but want more da...

Panel Recommends Approving Hologic Sterilization

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FDA advisors recommend approving a pre-market application for Hologics Adiana permanent contraception.