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ANDA Approval Times Get Optimistic Estimate In Budget Request

 
• By Derrick Gingery

US FDA has historically overestimated generic review performance in budget requests, but recently underestimated the number of ANDAs it expects to approve.

Samples of medicines, tablets, capsules, vitamins, and placebo

The US FDA continues to give overly optimistic predictions of median ANDA times to approval, a popular performance measure for the generic drugs program.

FDA estimates that the median approval time will be 38.25 months in fiscal year 2017, a decrease of more than...

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Why ACIP Could Get Away With Unscientific Actions US FDA Cannot

 
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More from Agency Leadership

‘Major Statements’ Are Major Target Of US FDA’s New TV Ad Crackdown

 
• By Sarah Karlin-Smith, Cathy Kelly, and Derrick Gingery

The bolus of untitled letters signals the FDA's approach to enforcement of the final rule on the presentation of the major statement in direct-to-consumer TV ads in a clear, conspicuous and neutral matter.

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Emer Cooke’s EMA Leadership Extended Until 2027 Ahead Of Planned Retirement

 
• By Eliza Slawther

The European Medicines Agency’s executive director Emer Cooke will remain in her post until April 2027, a shorter timeframe than the full five-year term for an executive director’s mandate at the agency, as she will be due to retire.