1. Medtech Insight
  2. >>Device Area
  3. >>Combination Products

Gottlieb Promises More Balance On Combination Product Reviews

 
• By Sue Darcey

US FDA Commissioner Scott Gottlieb told a Medical Device Manufacturers Association crowd that he will try to assure more balance between device and drug regulatory leads for combination product reviews at the agency.

US FDA is working hard to create a more efficient consultation process between different regulatory centers, but also one that is fair for all sponsors of combination products, whether for combination device and drug, device and biologic, or drug and biologic products, Scott Gottlieb said May 3.

But device manufacturers continue to perceive that it is the drug center at FDA, rather than the device center, that...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Combination Products

Injuries And Deaths Linked To Baxter Infusion Pump

 
• By Brian Bossetta

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By Elizabeth Orr

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.

European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

More from Device Area

Daye Breaks Into Hormone Self-Testing, Adds New Data To Extensive Gynecology Database

 
• By Natasha Barrow

Daye is launching an at-home reproductive hormone testing service in the UK, utilizing a painless upper arm blood collection method. The product’s UKAS lab accreditation helps build credibility with healthcare providers.

Zimmer Biomet Targets 2027 Launch For Semi-Autonomous Orthopedic Robot After Monogram Acquisition

 
• By Shubham Singh

Zimmer Biomet expects the Monogram deal to meet its financial and strategic criteria, be neutral to adjusted earnings per share from 2025 through 2027 and become accretive thereafter.

Injuries And Deaths Linked To Boston Scientific Cardiac Devices. Company Responds

 
• By Brian Bossetta

The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.