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Emerging Technology Approvals Among FDA Office of Pharmaceutical Quality’s First-Year Achievements

The positive impact that FDA’s Office of Pharmaceutical Quality (OPQ) has had during its first year in operation includes the extra support the agency has been able to provide for emerging technologies, as witnessed by the agency’s first approvals of drug products using continuous manufacturing and 3D printing.

FDA’s OPQ Adapts ANDA Risk-Ranking Model for Drug Substance Reviews

FDA’s Office of Pharmaceutical Quality (OPQ) has adapted the risk-ranking model developed for abbreviated new drug application (ANDA) reviews to its review of drug substances, with the goal of improving communications internally and with industry regarding API risks and deficiencies, and in turn, the overall efficiency and predictability of the process.

IPQ Monthly Update – January 2016 in Review

FDA’s vision of a quality regulatory process that would be more efficient, science-based, review/inspection coherent, and process improvement and product supply friendly took more concrete shape during 2015. The January Monthly Update explores what the progress looks like across CDER’s Offices of Generic Drugs and Pharmaceutical Quality. Also in focus is the complex web of challenges that a global drug distribution system presents in trying to identify and trace products and what regulators and industry are trying to do to deal with it.

Drug Product Quality Dashboard Taking Shape at FDA in Wake of OPQ Integration and Expanding Knowledge Base

The vision of having a product quality dashboard that would help guide FDA in regulating drug product lifecycles is emerging into more concrete form as the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) begins its second year.

Starting Materials Remains a Challenging Issue for Both Regulators and Industry; FDA DMF Assessments Show SM Information Gaps

FDA reviewers are reporting that firms producing active pharmaceutical ingredients (APIs) are not always providing adequate information on their starting material (SM) decisions or on the fate and purge of process impurities in their Type II drug master file (DMF) applications.

FDA’s API DMF Assessment Timelines Improve as eCTD Use Increases and OPQ’s New API Review Structure Takes Hold

The increasing use of the electronic common technical document (eCTD) for submitting Type II Drug Master Files (DMFs) has contributed to a significant reduction in the amount of time it is taking FDA to do DMF completeness assessments (CA), and a significantly higher percentage of the electronic filings are clearing the CA review on the […]

FDA’s Generics Office Overcomes Tough Challenges to Meet Year 3 GDUFA Goals, OGD’s Uhl Reports at GPhA Conference

A significant increase in controlled correspondences, easily correctable deficiencies, and information requests, along with a major reorganization, were among the tough challenges that the Office of Generic Drugs (OGD) overcame to meet the Year 3 goals of the Generic Drug User Fee Act (GDUFA) – the first year that goals came into play.

Challenges of Implementing U.S. and Global Serialization Mandates Compel Industry Cooperation

Pharmaceutical companies are reaching a clear understanding that they will have to work closely together, and with their supply chain partners, to address the serialization and tracing requirements of the Drug Supply Chain Security Act (DSCSA) as they unfold in stages through 2023.

IPQ Monthly Update — November/December 2015 in Review

With the ICH Q12 initiative operating as a catalyst, the dialogue has been intensifying on what is needed to make quality regulatory processes across the product lifecycle more coherent, efficient, process improvement and product supply friendly, and internationally harmonized. This IPQ Monthly Update departs from the usual format to provide a series of stories exploring the various dimensions of the lifecycle management regulatory challenge and the international effort to better address it....

ICH Q12 EWG Views Established Conditions as Pivotal in Evolving Lifecycle Regulation Internationally; EMA Workshop Provides Input

The ICH Q12 Expert Working Group (EWG) is viewing “established conditions” as a linchpin concept in its effort to define and drive a more improvement friendly, simplified, and harmonized regulatory approach to product lifecycle management internationally.
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