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Generic Drug Puzzle: Why Did ANDA Submissions Spike Again?

 
• By Derrick Gingery

Jump in March may have been "happenstance," but also could be concerning as US ANDA submissions reach near record pace.

FDA received another large bolus of generic drug applications in March and industry now is on pace to equal the annual record for submissions received set in fiscal year 2014.

The agency reported April 6 that it received 197 abbreviated new drug applications that month, a dramatic spike from January and February, when less than 60 were received each month....

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US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
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Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

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More from Biosimilars & Generics

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

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Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

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US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.