Developing a new medication can cost over $1 billion, depending on the drug’s complexity and expenses accrued via unsuccessful studies. Considering these costs, an optimized regulatory process is ...

The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on ...

Chemistry, manufacturing, and controls (CMC) is key in drug development, ensuring novel therapeutics’ consistency, quality, and safety. The approval process for new medications can take 10–15 years, ...

FDA announces CMC review pilot for drugs with expedited development The US Food and Drug Administration (FDA) announced on 31 October a limited chemistry, manufacturing and controls (CMC) development ...

Antibody-drug conjugates (ADCs) are transforming oncology with their ability to deliver potent cytotoxic agents directly to ...

Zifo announced today that 7 of the world's top 15 biopharma companies have adopted its Chemistry, Manufacturing, and Controls ...

Development and Readiness Pilot (CDRP) program supports the acceleration of manufacturing readiness for therapies with ...