Search results for " guidance" in Articles / App Notes
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FDA Provides Guidance on Bispecific Antibody Development Programs
FDA published final guidance on May 24, 2021 to provide industry and stakeholders with recommendations for the development of bispecific antibodies including recommendations for regulatory, quality, n…
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discusses the inclusion of a new FDA progr…
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EMA Invites Comments on New Guidance for Vaccine Development
The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication of…
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EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants
10, 2021, the agency announced that it is developing guidance to assist manufacturers in making changes to existing COVID-19 vaccines in order to treat these variants in the coronavirus.
A reflect…
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Emerging Therapies Test Existing Bioanalytical Methods
Current FDA guidance provides little direction on how to approach assay development and validation when using these emerging technologies, nor is there guidance for the application of more familiar te…
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Challenges in Analytical Method Development and Validation
Regulatory Considerations
BioPharm: What regulatory parameters exist for analytical method development and validation for biopharmaceuticals?
Krause (MedImmune): A FDA draft guidance for develop…
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Driving Improved Access to Biosimilars
Biosimilar advocates have been pressuring FDA for more guidance on biosimilars interchangeability, and an update to draft guidance that the agency had issued in 2017. In August 2018, in a letter (9) t…
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Biosimilar Quality Requirements
In May 2019, the agency published the draft guidance Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations (1) and the guidance Con…
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Regulatory Challenges in the QbD Paradigm
FDA has addressed this gap to some extent through its ongoing QbD pilot program, but more guidance is needed from the regulatory authorities to ensure widespread successful implementation of QbD (2). …
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Assessing Manufacturing Process Robustness
In 2011, FDA’s revised process validation (PV) guidance (7) extended ICH’s concepts to the pharmaceutical product lifecycle, an approach that is now being applied to cleaning validation and other area…