ARTICLES BY BIKASH CHATTERJEE

• FDA Steps Up Support For Advanced Manufacturing Technologies

  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 MOU is significant because it takes the next step in providing much-needed guidance and resources to the industry.

• Navigating The FDA’s Emergency Use Authorization Process

  The FDA has been authorized to grant Emergency Use Authorizations for SARS-CoV-2. This will impact both internal manufacturing and the CDMOs that drug sponsors employ. 

• Business Continuity & The Coronavirus: Are Your Pharma Operations At Risk?

  In the face of a pandemic, the value of a robust business continuity plan cannot be overstated. Organizations should actively evaluate those plans, focusing on service providers and partners. 

• New FDA Draft Guidance: Qualification Process For Drug Development Tools

  The FDA recently issued its draft guidance on the qualification process for drug development tools (DDTs), as part of the commitment mandated by the 21^st Century Cures Act. The draft guidance provides a high-level description of the intent and content of the DDT program, but it does not address evidentiary standards or performance criteria for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.