Search results for " guidance"

Article FDA Releases Draft Guidance on Emerging Manufacturing Technology
23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.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…

Article FDA Lists Guidance Documents Planned for 2013
The list reflects guidance documents currently under development as of the date of the posting, Jan. 31, 2013. Planned documents relevant to cGMP and compliance include: Quality Systems Approach t…

Article 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…

Resource Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009
FDA's Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009

Resource Guidance for Industry: Quality Considerations in Demonstrating Protein Product
FDA's guidance for Industry Quality Considerations in Demonstrating Protein Product

Resource Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
FDA's guidance on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

Resource EMA scientific guidance documents on biosimilar medicines
This page lists the scientific guidance documents on biosimilar medicines from EMA.

Resource FDA Guidance Documents
A searchable database of FDA guidance documents

Article 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…

Article 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 Krause (MedImmune): A FDA draft guidance for develop…

Next Page