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.
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.
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.
The US Food and Drug Administration (FDA) has issued a draft guidance to assist submitters of abbreviated new drug applications (ANDA) in minimizing differences between the user interface of a proposed generic drug-device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).
The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing how device sponsors should prepare and submit Pre-Request For Designation (Pre-RFD) submissions to seek early input from the agency during a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.
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.
The U.S. Food and Drug Administration (FDA) has released final guidance on current good manufacturing practice (CGMP) requirements for combination products.
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.
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.
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.