FDA Steps Up Support For Advanced Manufacturing Technologies

By Bikash Chatterjee, CEO, Pharmatech Associates

In its latest move to encourage the broader adoption of advanced manufacturing technologies, the FDA has entered into a memorandum of understanding (MOU) with the National Institute of Standards and Technology (NIST) that combines the strength of FDA’s regulatory expertise and NIST’s globally recognized precision characterization and standards.

The FDA must proactively evolve and prepare itself to accommodate the rapidly changing initiatives within industry that include the adoption of digital technologies and Industry 4.0, in addition to AMTs. Examine the potential of the MOU to provide critical technical guidance that could greatly standardize the approaches to implementing AMTs, such as those used in continuous manufacturing.