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Coronavirus Notebook: US FDA Cuts Hotline Hours, Regulatory Relief May Be Permanent, Trump's Hydroxychloroquine Prescription

 
• By Derrick Gingery

Dispatches from a world turned upside down include approval of more hydroxychloroquine ANDAs, a window into what post-pandemic regs at the US FDA might look like, and some bad news for night shift works who need coronavirus advice from the agency.

3D_Coronavirus
The FDA decided to reduce the hours its coronavirus emergency line will be available in order to meet current needs. • Source: Shutterstock

As the completely abnormal starts to feel routine, the Pink Sheet offers periodic dispatches about how the coronavirus pandemic is changing the operations of sponsors and regulators. Here are some recent stories from the United States.

In another potential sign of progress fighting the coronavirus pandemic, the FDA reduced the hours of its industry hotline for questions about diagnostic testing, personal protective equipment and other issues.

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More from Generics

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

 
• By Sarah Karlin-Smith

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.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

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

 
• By Derrick Gingery

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

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

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

More from Biosimilars & Generics

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.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.