An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US.

Continuous manufacturing (CM) sends materials directly and continuously to the next step of a process, eliminating hold times and reducing processing times. The potential benefits of CM include improved product quality, reduced waste, lower costs, and increased manufacturing flexibility and agility. Some pharmaceutical manufacturers have been hesitant to adopt CM owing to perceived regulatory risks such as increased time to regulatory approval and market entry, more difficulty submitting postapproval changes, and higher inspectional scrutiny.

Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment.

Background: Real-world data (RWD) from the Society for Vascular Surgery Vascular Quality Initiative (VQI) registry has been used to support US Food and Drug Administration (FDA) regulatory decisions regarding vascular devices. The variables of cost and time needed for these registry-based studies have not been previously compared to traditional, independent, industry studies that would otherwise have been conducted to support regulatory decisions.

Objectives: To determine the potential value (cost and time saving and return on investment) created by device evaluation studies using the VQI registry infrastructure.

Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions.

Background: Increasing generic drug price competition by facilitating abbreviated new drug applications (ANDA) submission may help patients have access to affordable care. This study examined factors associated with first ANDA submission for the brand drug to be copied [the "reference listed drug" (RLD)].

Methods: This study used several data sources from 1/1/2011 to 12/31/2017, including FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book), internal ANDA submission data, FDA's Product-Specific Guidances (PSGs), National Drug Code, and IQVIA National Sales Perspectives.

The impact of the abuse-deterrent reformulation of extended-release OxyContin on prescription pain reliever misuse and heroin initiation.

The introduction of abuse-deterrent OxyContin in 2010 was intended to reduce its misuse by making it more tamper resistant. However, some studies have suggested that this reformulation might have had unintended consequences, such as increases in heroin-related deaths. We used the 2005-2014 cross-sectional U.

Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology.

Generic drug products are approved by the US Food and Drug Administration (FDA) through Abbreviated New Drug Applications (ANDAs). The ANDA review and approval involves multiple offices across the FDA. Forecasting ANDA submissions can critically inform resource allocation and workload management.

Trends and economic drivers for United States naloxone pricing, January 2006 to February 2017.

Anecdotal evidence indicates that naloxone prices have risen in recent years, but limited research has examined the magnitude of these increases and potential causes. We contribute nationally representative evidence to help answer each of these questions, including wholesale pricing data from a proprietary drug sales database spanning January 2006 to February 2017. We find that all formulations of naloxone increased in price since 2006 except for Narcan Nasal Spray.

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

Introduction: An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied.

[Violence prevention in secondary schools: the Faustlos-curriculum for middle school].

Schools and kindergartens are particularly suitable for the implementation of violence prevention programs. Many German schools and kindergartens have securely established the violence prevention curriculum Faustlos. The Faustlos programs for kindergartens and elementary schools are now complemented with the version for middle schools.

[Behavior problems and identification of mental states in preschoolers].

Aim of the study is to present a method to map the ability of children to identify emotions and intentions in emotionally relevant situations (intentional and emotional reflectiveness). Moreover we analyze interrelation between this ability and behavior problems. Therefore we administered Story Stem Interviews with 70 children and added demand questions focusing emotions and intentions of diverse characters within the child constructed stories.

[Evaluation of the Faustlos-Curriculum for Kindergartens].

In this control group study the Faustlos-Kindergarten version was evaluated. This violence prevention program is based on strengthening social-emotional competences in children. The results of the pre-post-study in 7 intervention and 7 control kindergartens (N=124 children aged 4; 5-6 years) show significant improvements in the childrens' social-emotional competences and significant reduction of aggressive behavior in the Faustlos groups in contrast to the controls.

[Faustlos -- promotion of social-emotional competences in elementary schools and kindergartens].

Aggressive and violent behavior of children often is caused by a lack of social and emotional competences, which blocks constructive problem- and conflict-management. Therefore lots of different US-American prevention approaches for the promotion of crucial social competences have been developed. Faustlos is the first German violence prevention curriculum, which promotes the social and emotional competences of first grade pupils and kindergarten aged children.

[Mental representation, psychic structure, and behaviour problems in preschool children].

Mental health problems in terms of deviant behaviour and emotional problems are assumed in context with mental representations and indicators of internal psychic structure. In distinction to adults there is little empirical research concerning this matter. On the basis of Childrens' Play Narratives (MacArthur Story Stem Battery) we collected data about content-themes, structural indicators and process criteria of 73 preschool children and implicated these information with behaviour ratings of parents and kindergarden teachers.

[Preventing violence in schools--approaches and outcomes].

The article gives an overview of the development and evaluation of violence prevention efforts realized in and for schools. The different approaches are divided into structural and organizational measures, the promotion of violence prevention competencies of teachers, violence prevention programs for pupils, and multimodal programs. These approaches are analyzed with respect to contents and methods.