Search results for "FDA"
Article
The Bullish Outlook for Biosimilars
FDA is still developing its final regulations and guidelines pertaining to biosimilar approval in the US. While not formalized yet, preliminary guidance suggests that this pathway will require the com…
Article
Quality by Design and Extractable and Leachable Testing
FDA Guidance for Industry, Q8 (R2) Pharmaceutical Development describes the elements of QbD used in pharmaceutical development (2). The guidance outlines a series of proactive steps used to build qual…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (I…
Article
Essentials in Establishing and Using Design Space
FDA generally welcomes discussion on design space with applicants so be sure to discuss the design space and submission logic with FDA working groups as needed.
References
1. ICH, Q8(R2) Pharm…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
FDA defines “drug shortages” as “a situation in which the total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected demand at the …
Article
The Need for Advanced Process Modeling for New Therapeutic Biologics
FDA’s quality-by-design (QbD) and validation initiatives also encourage the use of modeling early on.
While QbD does not define manufacturing design space or specific protocols, it does discuss…
Article
Methods Accelerate Biosimilar Analysis
In May 2019, FDA published a draft guidance on the analytical assessment and other quality-related considerations for biosimilars, clarifying regulatory requirements and expectations for demonstration…
Article
Applying GMPs in Stages of Development
FDA, INDs for Phase 1 Studies of Drugs & Biotech Products [2], November 1995.
2. FDA, Draft Guidance: INDs-Approaches to Complying with CGMP’s for Phase 1 Drugs (CDER, CBER, Jan. 6, 2012)…
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
Last year also marked a significant step towards integrating continuous manufacturing into pharmaceutical production for a small-molecule drug when FDA approved, for the first time, a manufacturer’s c…
Article
Defining Risk Assessment of Aseptic Processes
In September 2004, FDA finalized their guidance for industry titled Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (1).
This document placed considerable e…