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May 02, 2016
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
The author looks at EUCAST’s role in tackling the spread of antimicrobial resistance, by creating definitions for a global consensus.
April 28, 2016
The agency holds a workshop to strengthen collaboration with healthcare providers.
April 25, 2016
The agency publishes draft guidance on assay development and validation for immunogenicity testing.
April 19, 2016
The guidance discusses the implementation of CMC postapproval changes through a comparability protocol.
PRAC said it has plans to review both canagliflozin and several direct-acting antivirals, after new study data showed potential risks associated with the drugs.
April 18, 2016
The agency published guidance on data integrity as it is relates to CGMP compliance.
April 15, 2016
FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.
The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.
FDA’s breakthrough drug initiative is more popular and successful than ever.