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The News in Depth

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.

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.

Industry is Urging Latin American Agencies to Cooperate in Filling Lifecycle Management Regulatory Gaps for Biologics

The Latin America Federation of the Pharmaceutical Industry (FIFARMA) is advocating the need for the agencies in the region to extend the progress they have been making in regulating the approval process for biologics and cooperate on filling the regulatory gaps for their life-cycle management.

More Structured, Interactive Process To Drive Convergence in Latin America Advocated by Biotech Product Regulators and Industry at CMC Strategy Forum in Brasilia

The need for a more structured, interactive process to drive convergence and resource sharing among the regulatory agencies of Central and South America – potentially drawing on elements of the European model – was a dominant theme among the industry and regulator participants in the second annual CMC Strategy Forum Latin America held again in late August 2015 in Brazil’s capitol city Brasilia....

IPEC Continues to Urge Family Approach in Dialogue with FDA on Improving Inactive Ingredient Database

IPEC-Americas and the Generic Pharmaceutical Association (GPhA) are continuing their advocacy of FDA incorporating a family approach in the toxicology assessment of excipients as they work with the agency on further improving the inactive ingredient database (IID) to support better drug development and more efficient FDA reviews.

Broad-Based ICH Q12 Expert Working Group Supporting Initiative’s Urgency and Viability, EWG Members Affirm at GPhA Conference

The broadening of the ICH Q12 Expert Working Group (EWG) to include parties not traditionally associated with the ICH process may be facilitating, rather than hindering, the effort to meet the tight timelines set up for the guideline’s completion as well as enhancing its global relevance, EWG members are affirming.
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