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To Prevent Shortages, US FDA Wants Sponsor To Provide Notifications Of Demand Spike

 
• By Derrick Gingery

Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.

empty blister pack
The FDA monitors data to try to anticipate demand spikes that could cause a drug shortage • Source: Shutterstock

Drug shortage staff at the US Food and Drug Administration are asking industry to notify them of demand spikes, even though it’s not required, so supply problems can be prevented.

Valerie Jensen, associate director of the FDA drug shortage staff, said on 1 December during an Alliance for a Stronger FDA webinar that the demand spike-relates shortage problem “is

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US FDA Expands Surprise Foreign Inspections

 
• 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.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
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Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

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Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
• By Dave Wallace

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.

More from Policy & Regulation

Tofidence And Tariffs - Organon Discusses Exposure Of Its Biosimilars Business

 
• By Dave Wallace

During Organon’s first-quarter results call, CEO Kevin Ali discussed the exposure of the biosimilars business to US tariffs, as well as pointing to the recent acquisition of Tofidence (tocilizumab-bavi) from Biogen as an opportunity for growth, as the segment saw a double-digit decline.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

 
• By Dave Wallace

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