In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Berlin Heart AG

www.berlinheart.com

Latest From Berlin Heart AG

FDA Assembling Advisors To Discuss Pediatric HDE Products

As part of a periodic review, FDA is bringing together experts to review several products that are conditionally available for pediatric use under the agency's Humanitarian Device Exemption program.

Regulation Cardiovascular

Safety Of Five Devices To Be Reviewed At FDA Pediatric Panel Meeting

A Pediatric Advisory Committee meeting is planned for Sept. 14 to assess safety data for five devices used in children, and almost a dozen other drugs and biologics.

Policy & Regulation Regulation

FDA Orphan Designations At Record Levels; Resources Need To Keep Up

The development of drugs and biologics for rare diseases has reached a regulatory milestone that underscores industry’s interest in the orphan drug market. FDA’s Office of Orphan Product Development is now granting one new orphan drug designation, on average, every day of the year. That activity underscores the success of the Orphan Drug Act, but creates a new problem: Finding the funding to support it.

BioPharmaceutical Regulation

FDA Orphan Designations At Record Levels; Resources Need To Keep Up

The development of drugs and biologics for rare diseases has reached a regulatory milestone that underscores industry’s interest in the orphan drug market. FDA’s Office of Orphan Product Development is now granting one new orphan drug designation, on average, every day of the year. That activity underscores the success of the Orphan Drug Act, but creates a new problem: Finding the funding to support it.

BioPharmaceutical Regulation
See All

Company Information

  • Industry
  • Medical Devices
    • Implantable Devices
  • Therapeutic Areas
  • Cardiovascular
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • Europe
      • Western Europe
        • Germany
  • Parent & Subsidiaries
  • Berlin Heart AG
  • Senior Management
  • Klaus Wuertenberger, CFO
    Pia-Maria Gorner, Dir., Mktg.
  • Contact Info
  • Berlin Heart AG
    Phone: (49) 30 8187 2600
    Wiesenweg 10
    Berlin, 12247
    Germany
Advertisement
Advertisement
UsernamePublicRestriction

Register