ARTICLES BY BIKASH CHATTERJEE
New FDA Draft Guidance: Qualification Process For Drug Development Tools
The FDA recently issued its draft guidance on the qualification process for drug development tools (DDTs), as part of the commitment mandated by the 21st Century Cures Act. The draft guidance provides a high-level description of the intent and content of the DDT program, but it does not address evidentiary standards or performance criteria for purposes of DDT qualification, leaving it to industry to propose the scientific argument and data package.
Understanding The FDA’s KASA Framework
The FDA's Knowledge-Aided Assessment & Structured Application Framework marks an ambitious step forward in standardizing and increasing the efficiency of the drug review process. Here's what it will take for the framework to succeed.
Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine
A race is being run to create the pharmaceutical manufacturing of the future and with Pharma 4.0, powerful market trends are shaping the running field.
Considerations For Biologic Drug Substance And Drug Product Testing
While the FDA does not explicitly define the testing required as a product moves through its development life cycle, recognized standards provide guidance based upon where you are in your drug development and clinical program. This article focuses on the considerations for building a testing strategy for a drug product when using a CMO.
Biopharma 4.0: A New Framework & Process For Digital Quality Management
Contrary to how it sounds, controlling information is not about withholding key documents or facts that are relevant to the CMO bidding process to see how the bidders react, or only supplying pertinent information if requested. In fact, it is exactly the opposite is true.
Best Practices For Measuring System Quality For Drug-Device Combination Products
Combination product development is a complex matter governed by different areas of regulatory oversight. In my previous article, we discussed which current good manufacturing practice (cGMP) requirements apply when drugs, devices, and biological products are combined, and the typical pitfalls to avoid when doing so.
Managing QMS Disparities Between Drugs And Devices For Combination Products
Combination products represent a remarkable opportunity as one of the most dynamic segments in the life sciences and are projected to grow to $115 billion by 2019.
4 Key Considerations When Engaging A New GMP Contract Service Provider
This article explores what is important when establishing an effective relationship with a CSP as the program moves from product and process design to commercial manufacturing.
FDA's New Quality Agreement Guidance: What It Says (And What It Fails To Say)
FDA’s new guidance for industry Contract Manufacturing Arrangements for Drugs: Quality Agreements specifically addresses seven elements that should be included in a quality agreement: quality unit activities, facilities and equipment, materials management, product-specific considerations, laboratory controls, documentation, and change control.
FDA’s New Quality Agreement Guidance — What It Says (And What It Fails To Say)
In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This guidance is timely, given the rise of the virtual biotech company in the development landscape. Most development programs now include the support of at least one contract service provider (CSP) for services that vary from early development contract research to commercial manufacturing and analytical support.