Search results for "FDA" in Articles / App Notes
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In May 2019, FDA published a draft guidance on the analytical assessment and other quality-related considerations for biosimilars, clarifying regulatory requirements and expectations for demonstration…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 FDA, Draft Guidance: INDs-Approaches to Complying with CGMP’s for Phase 1 Drugs (CDER, CBER, Jan. 6, 2012)…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…
Article
Design and Qualification of Single-Use Systems
International Council for Harmonization (ICH) Q7, European Medicines Agency (EMA) Q7, and FDA
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients incorporate essentially…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
…eloping a biosimilar and something that is expected by both the European Medicines Agency (EMA) and FDA, according to Gino Grampp, R&D policy director for Amgen. Physicochemical assays for testing of…
Article
Biopharma Manufacturers Respond to Ebola Crisis
FDA also is working with WHO’s International Coalition of Medicines Regulatory Authorities (ICMRA) to facilitate testing of experimental treatments and to provide more flexibility for meeting manufact…