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Sign Of Normalcy? US FDA Schedules Meeting But Pauses Non-COVID Guidance Development

 
• By Derrick Gingery

As the agency and country plot the steps to reopening, a full resumption of activities still seems a long way off.

Stop Wait Go Glossy Button, Vector illustration

Those in the pharma industry looking for any sign of soon returning to normal life may have been encouraged by a recent Federal Register notice from the US Food and Drug Administration.

The agency announced a meeting on modernizing its data strategy was rescheduled for 30 June and will be held in-person...

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More from Regulation

EU Green Claims Directive: Commission Says It ‘Has Not Withdrawn’ From Negotiations

 
• By David Ridley

What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.

German Switch Committee Supports OTC Melatonin And Acyclovir, Rejects Rupatadine

 
• By David Ridley

Germany’s Expert Committee for Prescription supports the Rx-to-OTC switches of melatonin and buccal acyclovir but rejects rupatadine.

Green Regulation Is ‘A Baseline Not A Burden’ – Behind Opella’s B Corp Journey

 
• By David Ridley

“For us, regulation is the floor, not the ceiling,” Opella's chief sustainability officer Marissa Saretsky tells HBW Insight as the firm gains B Corp Certification. Other topics covered in this exclusive interview include Opella's position on the revised Urban Wastewater Treatment Directive.

US FDA: No Replacement Yet For Animal Methods In Testing Systemic Effects Of Sunscreens

 
• By Lauren Nardella

While FDA fully supports the recent roadmap to reduce and eliminate animal testing, animal tests are still necessary for assessing systemic effects, says Jacqueline Corrigan-Curay, acting director for CDER, during a House Energy and Commerce Health Subcommittee hearing.

More from Policy & Regulation

Green Regulation Is ‘A Baseline Not A Burden’ – Behind Opella’s B Corp Journey

 
• By David Ridley

“For us, regulation is the floor, not the ceiling,” Opella's chief sustainability officer Marissa Saretsky tells HBW Insight as the firm gains B Corp Certification. Other topics covered in this exclusive interview include Opella's position on the revised Urban Wastewater Treatment Directive.

FDA Warns Whoop BPI App Is Unauthorized Device; Firm Says Wearable Is A Wellness Tool

 
• By Brian Bossetta

Recent FDA warning letter claims Boston firm specializing in wearable technology marketed a blood pressure device without agency approval, but the company rejects the assertion and says the agency is out of step with federal regulations.

Questions For FDA On OTC Switches, Alternative Tests And Budget Cuts At OMUFA Hearing

 
• By Malcolm Spicer

Texas Democrat Lizzie Fletcher didn’t pose questions for witnesses at House Health Subcommittee hearing but used her floor time to question whether Congress will keep federal agencies afloat. “I have real concerns that even if we reauthorize these programs, we won't have the funding or the staff to