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Gottlieb Initiative Will Expedite Device, Drug Pain Control Alternatives, FDA Chief Says

 
• By Sue Darcey

US FDA Chief Scott Gottlieb said he will soon announce an initiative to help expedite approvals of both innovative devices and drugs that are designed to control pain as an alternative to opioid prescriptions commonly written by doctors.

An ampoule Opioid next to it is a note written in English Opioid epidemic. All around, many tablets and syringes are scattered.

Sponsors of new pain-control devices should get a boost from what FDA Commissioner Scott Gottlieb said will be “a new initiative for companies that have products to treat pain,” during a May 3 talk at the Medical Device Manufacturers Association meeting in Washington, D.C.

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More from United States

FDA Reverses Course, Allows Some Telework For Reviewers

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Medtech Looks For Relief As Trump Hits Pause On Most Tariffs

 
• By Elizabeth Orr

The medtech industry hopes to use a 90-day pause on tariffs to negotiate a “zero for zero” exemption. However, recent public comments from President Donald Trump suggest the health care sector may still be at risk.

Biotech Leader Predicts Delays On Device Approvals As FDA Makes Life-Saving Drugs Sole Priority

 
• By Natasha Barrow

Nawal Ouzren, Sensorion CEO and director, shared the latest industry reaction to US FDA layoffs at the McDermott Will & Emery European Health and Life Sciences Symposium in Paris.

Shuren Expects Longer CDRH Review Times

 
• By Elizabeth Orr

The FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems.

More from North America

Shuren Expects Longer CDRH Review Times

 
• By Elizabeth Orr

The FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems.

Draft FDA Reorganization Would Unite All Product Centers

 
• By Sarah Karlin-Smith

Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.

End Of The Road? Court LDT Decision May Leave FDA With Few Options

 
• By Brian Bossetta

Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?