GENERIC DRUG REGULATION
This article was originally published in The Gold Sheet
...is being closely examined at FDA and the U.S. Pharmacopeia in the search for ways to streamline the approval process and update the standards to match current manufacturing science. FDA’s generics office is implementing a range of strategies aimed at reducing ANDA approval times and addressing workload issues including early review of dissolution testing and eliminating re-reviews of drug master files. Dissolution methods for alternate dosage forms and better coverage of marketed substances and products by USP monographs are other facets of the effort to clarify the regulatory standards for generic products. At a recent USP conference, participants explored the current problems drug product manufacturers face in assuring that excipients will serve the more complex purposes for which they are being used. USP excipient initiatives include updating its guidance on pharmaceutical water.
You may also be interested in...
Drug manufacturers are adopting QbD but there are exceptions, especially among some generics firms, McKinsey finds in industry survey. The top challenge to further adoption: misalignment between R&D and commercial operations. Second is a lack of belief in the business case. However, the cost turns out to be low and the financial reward high, McKinsey says.
Using QbD to set specs that make a difference to patients is hard but important work, FDA's Woodcock says. Prasugrel, levothyroxine, pallodone examples explored. How to establish a 'work space.' How to make the right correlations.
As biotech firms begin to pilot QbD they wrestle with FDA over non-critical process parameters, postapproval changes and more. They are exploring how to define design spaces, change them, identify their edges. And they're still wondering what regulatory relief they might get in return for investing in quality-by-design studies.