The path to successful product development for medical device companies is rife with roadblocks. The recession has only added to the pressures of mounting regulatory requirements, particularly those ...

This framework is the second that the agency has introduced in recent months to streamline biosimilar development in the hopes of lowering drug prices.

The U.S. Food and Drug Administration has launched a project to overhaul its application development process to provide management with a view into the agency’s IT projects. The 12-month project, ...

The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

When a development team is working on a piece of software, and they have a fundamental question about how the piece of software will be treated at FDA, the regulatory affairs professional cannot ...

The execution of the U.S. Army Medical Research and Materiel Command’s mission to create medical products for the warfighter is intricate. A product manager must adhere to a long list of acquisition ...

Creating medical technology products brings with it high risks and cost but can also generate huge rewards. Medical product development combines the challenges of creating systems with ...

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...

Every founder and CTO wants their software product development to be accomplished on time and bring a surprisingly good result, but how can you guarantee it? We have created over 100 tech products for ...

In a consumer-driven economy, meeting customers' needs and wants has become paramount in generating long-term success and growth. Product development is key to maintaining and acquiring customers and ...