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Latest News | 15 March 2013

FDA Withdraws Approval for Impax's Budeprion after Bioequivalence Concerns Raised

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The US Food and Drug Administration (FDA) announced today that it is formally withdrawing the approval of Impax Laboratory's Buproprion Hydrochloride extended release 300mg tablets (Budeprion XL 300 Read More...

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Latest News | 22 February 2013

FDA Draft Guidance Aims to Clarify Difference between Recalls and Removals

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When is a recall not really a recall? Between the US Food and Drug Administration (FDA) and industry, this has long been a point of contention.BackgroundRecall regulations stipulate that any action Read More...

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Latest News | 4 January 2013

In Unusual Move, FDA Withdraws OMB Submission to Focus on Changes to Device Program

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If you're waiting for the US Food and Drug Administration's (FDA) guidance on planned changes to its medical device pre-submission meeting program, you may have to wait a bit longer.In a highly Read More...

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Latest News | 26 June 2012

Citing a Change in Thinking, FDA Withdraws Lupus Product Guidance

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The US Food and Drug Administration (FDA) said it is withdrawing a guidance document published in June 2010 in light of the document no longer reflecting its current thinking on the topic.In its 26 Read More...

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Latest News | 7 June 2012

Pfizer Withdraws Indication for RA Drug After It Fails to Complete Required Study

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The US Food and Drug Administration (FDA) said Pfizer is withdrawing an indication for its rheumatoid arthritis (RA) drug Celebrex after Pfizer indicated it would not be able to complete a mandated Read More...

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