The term Secure Product Development Framework (SPDF) was introduced by FDA in the draft guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" ...

Goldsack is the founder and chief executive officer of the Digital Medicine Society (DiMe). In an industry known for its caution, the Food and Drug Administration’s decision to rapidly deploy ...

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 pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...

Appili provides update on Aditxt (ADTX) transaction and encourages shareholders to vote their shares as soon as possible for the November 6, 2024 shareholders meeting HALIFAX, Nova Scotia, Oct. 31, ...

An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

With all AI related to New Product Development & Marketing, it’s early days full of experimentation & important learnings. To explore the latest and most promising use cases, I spoke with cutting-edge ...

Product development is the engine of innovation—shaping industries, fueling growth and turning bold ideas into real-world impact. But the journey from concept to launch can be filled with friction.