ARTICLES BY JOF ENRIQUEZ

  • FDA Launches Oncology Center of Excellence, Appoints Pazdur As Director
    FDA Launches Oncology Center of Excellence, Appoints Pazdur As Director

    The U.S. Food and Drug Administration (FDA) has officially launched its Oncology Center of Excellence (OCE) to coordinate the clinical review of drugs, biologics, and devices across the agency’s three medical product centers. Dr. Richard Pazdur, FDA's cancer drug director since 2005, will lead OCE.

  • FDA Issues Two Draft Guidances On Medical Product Communications
    FDA Issues Two Draft Guidances On Medical Product Communications

    The first deals with communication by firms of health care economic information (HCEI) to payors, including about investigational drugs and devices that are not yet approved or cleared for any use. The second pertains to medical product communications that include data and information not contained in product labeling, but concerning the approved or cleared uses of those products.

  • FDA Touts EvGen, IMEDS Programs Ensuring Patient Safety
    FDA Touts EvGen, IMEDS Programs Ensuring Patient Safety

    The U.S. Food and Drug Administration (FDA) unveiled a website for its National Medical Evidence Generation Collaborative (EvGen), intended to bring wider access to high-quality scientific evidence supporting the safe use of FDA-regulated products.

  • FDA Describes How Interface Design And Human Factors Support Approval Of Generic Combination Products
    FDA Describes How Interface Design And Human Factors Support Approval Of Generic Combination Products

    The US Food and Drug Administration (FDA) has issued a draft guidance to assist submitters of abbreviated new drug applications (ANDA) in minimizing differences between the user interface of a proposed generic drug-device combination product and the user interface of its Reference Listed Drug (RLD).

  • FDA Explains How To Prepare Pre-Request For Designation Submissions
    FDA Explains How To Prepare Pre-Request For Designation Submissions

    The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing how device sponsors should prepare and submit Pre-Request For Designation (Pre-RFD) submissions to seek early input from the agency during a combination product's early stage of development, when the sponsor is contemplating a specific configuration of the product.

  • Califf Stepping Down As FDA Commissioner As Trump Considers Replacement
    Califf Stepping Down As FDA Commissioner As Trump Considers Replacement

    Replacing Califf on an interim basis is Dr. Stephen Ostroff, who served in the same capacity before Califf assumed his position at the helm of the agency just over a year ago.

  • FDA Issues Final Guidance On CGMP Requirements For Combination Products
    FDA Issues Final Guidance On CGMP Requirements For Combination Products

    The U.S. Food and Drug Administration (FDA) has released final guidance on current good manufacturing practice (CGMP) requirements for combination products.

  • St. Jude Issues Cybersecurity Update For Merlin Monitoring System
    St. Jude Issues Cybersecurity Update For Merlin Monitoring System

    St. Jude Medical has released a software patch to address cybersecurity vulnerabilities confirmed by the U.S. Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) affecting St. Jude's implantable cardiac devices and corresponding Merlin@home Transmitters.

  • Novo Nordisk, Glooko To Jointly Offer Digital Health Solutions For Diabetics
    Novo Nordisk, Glooko To Jointly Offer Digital Health Solutions For Diabetics

    Danish pharmaceutical company Novo Nordisk is working with Silicon Valley startup Glooko in launching jointly-developed and branded digital health solutions to help diabetics better manage their condition. The new offerings will leverage Glooko's mobile and web platforms and Novo Nordisk's expertise in diabetes management.

  • Aspect Biosystems One Of 15 New Partnerships For J&J
    Aspect Biosystems One Of 15 New Partnerships For J&J

    Johnson & Johnson's (J&J) DePuy Synthes unit, through J&J Innovation, is partnering with Canadian biotech company Aspect Biosystems to research and make a prototype artificial meniscus using Aspect's proprietary Lab-on-a-Printer 3D-printing technology.

More From Jof Enriquez
Jof Enriquez

Jof Enriquez

Jof Enriquez is a contributing writer for Med Device Online, Photonics Online, and RF Globalnet. He has written about the healthcare and medical technology industry for many years, covering topics such as medical devices, life sciences, business news, industry events, medical research, nursing, and digital health. He is a registered nurse and a medical copywriter for physicians, home care agencies, nursing blogs, and healthcare startups. You can follow Jof on Twitter at @jofenriq.