The US Food and Drug Administration (FDA) on Monday issued a statement explaining how the agency can facilitate the development of investigational products to diagnose, treat and prevent emerging ...

The FDA released updated guidance on May 29, 2026, formalizing expectations for human factors information in medical device ...

Top officials at the US Food and Drug Administration (FDA) say the agency is developing a new, less formal, way for industry to request input on how combination products will be regulated. Combination ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

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 ...

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 Food and Drug Administration (FDA) published a pair of discussion papers this week in an effort to outline areas artificial intelligence and machine learning may help in manufacturing ...

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 An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy ...

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

Hangzhou Qihan Biotech Co., Ltd. ("Qihan" or "Qihan Biotech" or "the Company"), an industry leader in applying multiplexable ...

Dthera ™ Sciences, the leading digital therapeutic company focusing on the elderly and individuals with neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has ...