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, ...

Overcoming common challenges with today’s biologics, such as developing devices for high-concentration subcutaneous ...

Global harmonization of CMC guidelines is a key focus for top pharmaceutical consultants. Variations in regulatory requirements across regions often create inefficiencies in drug development—for ...

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 ...

Please provide your email address to receive an email when new articles are posted on . An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy ...

TEMECULA, CA, UNITED STATES, February 20, 2026 /EINPresswire.com/ — Dr. Goodenowe Dietary Therapeutics LLC, a U.S.-based company formed to advance selected dietary ...

Or the innovator needs to petition FDA to come up with a new classification for the product that, not coincidentally, involves much the same level of evidence as getting a class III product approved.