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Dark, Then Dawn: ANDA Workload Approaching Steady State After 2014 Eruption

 
• By Derrick Gingery

FDA Office of Generic Drugs' output is beginning to compete with, rather than be overwhelmed by, sponsors' input.

Steady state, here we come! It's not the most exciting rallying cry, but for FDA's Office of Generic Drugs, it's an important target, and one OGD seems to be approaching as it now frequently approves more applications than it receives in a given month.

After June 2014, when a record number of ANDAs were submitted, output from the Office of Generic Drugs began to compete with,

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More from United States

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

 
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Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

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• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

More from North America

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
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• By Sarah Karlin-Smith

The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.