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 ...

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 ...

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

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 (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

The US Food and Drug Administration (FDA) has released a new draft guidance on the use of artificial intelligence (AI) that produces data or information that supports regulatory decision-making in ...

The US Food and Drug Administration (FDA) has proposed guidance on the types of scientifically valid prior knowledge sponsors should consider when developing certain gene therapies (GT). The agency ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

This Brush Up is sponsored by MilliporeSigma. Learn more about therapeutic synthesis pathways. Drug development is a process that spans many years, from the initial phase of identifying potential drug ...

Regulatory acceptance of Digital Health Technology (DHT) -derived endpoints can be a long, multifaceted and costly process. Success relies on establishing a global strategy as part of the development ...

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