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FDA Tabling Public Biosimilar Discussions While Digesting Complexities of New Legislation

FDA speakers at recent conferences have been open about their inability to discuss biosimilar issues at this time, while they digest the implications of the recently-passed Patient Protection and Affordable Care Act (PPACA)....

FDA Wants to See More Transparency Between Drug Companies and Contractors on Sponsor’s Application and Contractor’s GMP Status

FDA investigators will be looking for more transparency between a sponsor and its contract sites regarding the sponsor’s drug application commitments and the contractor's plant-wide GMP status, FDA Cincinnati District Investigator and Preapproval Manager Kathleen Culver emphasized at a Global Outsourcing Conference at Xavier University on June 14....

FDA Proposing More Transparency on Inspection Findings, Recalls, and Drug Filings

An FDA task force released on May 19 a set of transparency principles for public comment which propose to change what GMP and CMC documents and information are available to the public and with what timing. The proposals include making more information available more rapidly regarding GMP inspections, enforcement activities, and investigational, marketing and supplemental filings....

European Trade Associations Step Up to the Plate on Drug Counterfeiting

Two trade associations in Europe, through separate but related efforts, are advancing the dialogue on preventing counterfeit medicines from entering the legitimate drug supply chain: one by publishing a set of guiding principles to call attention to the issue; the other by successfully executing a pilot program on security of drug products in the supply chain....

Process Modeling in Focus for EU and US Reviewers

The understanding of the potential uses and value of models in facilitating manufacturers’ development efforts and helping regulators understand their complex processes is growing....

FDA Views Clinical Linkages as Key QbD Implementation Gap

As quality-by-design (QbD) implementation progresses, FDA is becoming aware of the scientific gaps that still need to be filled in. One area in particular that has generated considerable attention among industry and regulators is “understanding the link between what that product is and how it works in the patient – that is, integrating the field of biopharmaceutics into QbD,” ONDQA Acting Deputy Director Christine Moore stressed at a recent conference.
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