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

PDUFA First: Fees To Support US FDA Device Center Staff

 
• By Derrick Gingery

To enhance combination product reviews, drug-fee revenue will pay for related positions in the agency's Center for Devices and Radiological Health.

Drug user-fees will support staff in US FDA's device center for the first time beginning in fiscal year 2018.

The move does not stem from altruism by pharmaceutical sponsors and FDA signing on to the PDUFA VI agreement. Rather,...

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New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products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The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products.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

ForSight Sets Its Sights On Automating Delicate Eye Procedures

 
• By Marion Webb

ForSight Robotics is developing a robotic platform to automate cataract and other eye surgeries, aiming to ease surgeon strain and expand access. Backed by $200m in total funding, it's targeting a first human surgery using Oryom by year-end and is in discussions with US FDA.

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.

Private Equity Firm Archimed To Buy ZimVie As Antitrust Concerns Sideline Strategic Buyers

 
• By Marion Webb

Archimed will acquire dental implant firm ZimVie for $730m in a deal that reflects private equity’s growing role in medtech M&A, as strategic buyers face antitrust scrutiny. The deal includes a 125% premium and a 40-day window for competing offers.