FDA guidelines on Continuous Manufacturing

On the 28th of February, FDA Commissioner Scott Gottlieb, and Janet Woodcock, director of the Center for Drug Evaluation and Research, released a statement on the FDA’s modern approach to advanced pharmaceutical manufacturing (you can find the full statement here).

The FDA issued a draft guidance to industry to help further support the development and implementation of continuous manufacturing for branded, generic, and over-the-counter drugs.

After a thorough analysis of the draft guidance to industry, we are confident that CONTINUUS’ technology and quality strategy are aligned with this document.

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