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 ...
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 ...
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 ...
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 ...
The US Food and Drug Administration (FDA) has released a new draft guidance on the use of artificial intelligence (AI) that produces data or information that supports regulatory decision-making in ...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 FDA’s May 2026 guidance on cell and gene therapies provides for CMC flexibilities while insisting on quality and ...
On May 29, 2026, FDA released updated guidance on the content of human factors information required in medical device marketing submissions. This is just the latest signal that usability engineering ...
Pharmaceutical Technology on MSNOpinion
Rethinking sterile product development for manufacturing success
How evolving development priorities are helping organisations build manufacturing knowledge from the earliest stages of ...
As biologics grow increasingly sophisticated, formulation development must become more predictive and data driven.
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 ...
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