Regulatory Strategy: An Overview

2021 ◽  
pp. 683-691
Author(s):  
Palchi Rusia
Keyword(s):  
Regulatory Strategy

Idiographic Dynamics of Positive Affect in GAD

2020 ◽  
Vol 36 (3) ◽  
pp. 500-509
Author(s):  
Hannah G. Bosley ◽  
Devon B. Sandel ◽  
Aaron J. Fisher
Keyword(s):  
Positive Affect ◽  
Structural Equation ◽  
Alternative Hypothesis ◽  
Equation Model ◽  
Aggregated Data ◽  
Regulatory Strategy ◽  
Constant State ◽  
Automatic Search ◽  
Time Lagged ◽  
Exploratory Procedure

Abstract. Generalized anxiety disorder (GAD) is associated with worry and emotion regulation difficulties. The contrast-avoidance model suggests that individuals with GAD use worry to regulate emotion: by worrying, they maintain a constant state of negative affect (NA), avoiding a feared sudden shift into NA. We tested an extension of this model to positive affect (PA). During a week-long ecological momentary assessment (EMA) period, 96 undergraduates with a GAD analog provided four daily measurements of worry, dampening (i.e., PA suppression), and PA. We hypothesized a time-lagged mediation relationship in which higher worry predicts later dampening, and dampening predicts subsequently lower PA. A lag-2 structural equation model was fit to the group-aggregated data and to each individual time-series to test this hypothesis. Although worry and PA were negatively correlated in 87 participants, our model was not supported at the nomothetic level. However, idiographically, our model was well-fit for about a third (38.5%) of participants. We then used automatic search as an idiographic exploratory procedure to detect other time-lagged relationships between these constructs. While 46 individuals exhibited some cross-lagged relationships, no clear pattern emerged across participants. An alternative hypothesis about the speed of the relationship between variables is discussed using contemporaneous correlations of worry, dampening, and PA. Findings suggest heterogeneity in the function of worry as a regulatory strategy, and the importance of temporal scale for detection of time-lagged effects.

Structure, expression, chromosomal location and product of the gene encoding Adh2 in Petunia.

Genetics ◽  
1993 ◽  
Vol 133 (4) ◽  
pp. 999-1007
Author(s):  
R G Gregerson ◽  
L Cameron ◽  
M McLean ◽  
P Dennis ◽  
J Strommer
Keyword(s):  
Chromosomal Location ◽  
Higher Plants ◽  
Gene Encoding ◽  
Genomic Libraries ◽  
Regulatory Strategy ◽  
Adh1 Gene ◽  
Adh Genes ◽  
Genes Encoding ◽  
Adh Gene ◽  
Polymerase Chain

Abstract In most higher plants the genes encoding alcohol dehydrogenase comprise a small gene family, usually with two members. The Adh1 gene of Petunia has been cloned and analyzed, but a second identifiable gene was not recovered from any of three genomic libraries. We have therefore employed the polymerase chain reaction to obtain the major portion of a second Adh gene. From sequence, mapping and northern data we conclude this gene encodes ADH2, the major anaerobically inducible Adh gene of Petunia. The availability of both Adh1 and Adh2 from Petunia has permitted us to compare their structures and patterns of expression to those of the well-studied Adh genes of maize, of which one is highly expressed developmentally, while both are induced in response to hypoxia. Despite their evolutionary distance, evidenced by deduced amino acid sequence as well as taxonomic classification, the pairs of genes are regulated in strikingly similar ways in maize and Petunia. Our findings suggest a significant biological basis for the regulatory strategy employed by these distant species for differential expression of multiple Adh genes.

505(b) (2) - A smart pathway to differentiate from competitive, low margin environment of generics

2021 ◽  
pp. 174113432098786
Author(s):  
Pooja Rathee ◽  
Swagat Tripathy ◽  
Sahil Khatter ◽  
BP Patra ◽  
PN Murthy ◽  
...  
Keyword(s):  
Clinical Studies ◽  
Lower Cost ◽  
Development Program ◽  
New Product ◽  
Potential Productivity ◽  
Defense Strategies ◽  
Market Launch ◽  
Regulatory Strategy ◽  
Limited Change ◽  
Early Market

Purpose 505(b) (2) application is one of the advantageous ways of regulatory submission. This submission approach can lead to fast-track approval for wide-ranging products, exclusively for those that exemplify a limited change from formerly approved drug. Safety and efficacy evidence in terms of non-clinical and clinical portion of the Reference Listed Drug (RLD), are trusted upon. Additionally, supplementary data essentially required to establish comparability with the RLD, are presented in the dossier. Methods This retrospective analysis is to understand the FDA's expectations and avoid errors in terms of data support approval for a new product submitted under the 505 (b) (2) route. The current script is an analysis on how to architect 505(b) (2) regulatory strategy by developing a different set of documents/information. Results The ultimate goal of this review is to allow drug developers to easily navigate through various 505 (b) (2) submissions and defense strategies for registration processes available to the new drug manufacturers and to understand an effective, safer filing route by facilitating early market launch with a prospect of lower cost. Conclusion Before considering option 505 (b) (2), general companies should have a good understanding of product’s potential productivity, scalability, patent infringement, expensive clinical studies and/or non-clinical studies to appropriately strategize scientific and commercial opportunities. This leverage will potentially quicken the development program and will definitely lower the clinical and regulatory risk of new product entrants.

scholarly journals Effectiveness of intervention on behaviour change against use of non-biodegradable plastic bags: a systematic review

2021 ◽  
Vol 2 (1) ◽  
Author(s):  
Gbadebo Collins Adeyanju ◽  
Teslin Maria Augustine ◽  
Stefan Volkmann ◽  
Usman Adetunji Oyebamiji ◽  
Sonia Ran ◽  
...  
Keyword(s):  
Behaviour Change ◽  
Methodological Quality ◽  
Journal Articles ◽  
Inclusion Criteria ◽  
Government Regulations ◽  
Plastic Bags ◽  
Regulatory Strategy ◽  
Plastic Bag ◽  
Single Use ◽  
Biological Decomposition

AbstractThe devastating impacts that bio-degradable products such as plastic bags are having on human health, wildlife, and the environment is enormous, especially single-use once. Single-use plastics are non-biodegradable products and does not undergo biological decomposition nor degenerate. This review examines various government regulations targeted at changing behaviour against plastic bags consumption and their effectiveness. Following a rigorous search in 13 databases, including PubMed, Science Direct, Springer Nature, etc. only 17 peer-reviewed journal articles that are published between 2000 and 2019 and met the inclusion criteria were included in the study. Each study’s methodological quality was assessed using the GRADE system, and data were extracted using a uniquely designed form. The results revealed that regulations based solely on the thickness of plastic bags does not reduce plastic bags consumption. However, regulations focused on banning ‘single-use’ plastic bag usage, imposing higher taxes and levies on consumers, significantly reduce plastic bags consumption. Overall, the latter is considered the most effective. Also, the results show that attitude, perception and behaviour change toward bio-degradable products or climate-friendly behaviour can be significantly influenced by public policy or regulations. Although the behaviour seems short-lived in some countries, therefore further studies need to probe on why. Also, the absence of a national regulatory strategy in North America reduced the inclusion of studies from the region, hence need for more research focusing on sub-national regulations.

scholarly journals Repression of Prespliceosome Complex Formation at Two Distinct Steps by Fox-1/Fox-2 Proteins

2008 ◽  
Vol 28 (17) ◽  
pp. 5507-5516 ◽  
Author(s):  
Hua-Lin Zhou ◽  
Hua Lou
Keyword(s):  
Alternative Splicing ◽  
Complex Formation ◽  
Biochemical Analysis ◽  
Expression Control ◽  
Regulatory Strategy ◽  
Gene Expression Control ◽  
Splicing Regulator ◽  
Specific Alternative ◽  
Novel Strategy ◽  
Robust Regulation

ABSTRACT Precise and robust regulation of alternative splicing provides cells with an essential means of gene expression control. However, the mechanisms that ensure the tight control of tissue-specific alternative splicing are not well understood. It has been demonstrated that robust regulation often results from the contributions of multiple factors to one particular splicing pathway. We report here a novel strategy used by a single splicing regulator that blocks the formation of two distinct prespliceosome complexes to achieve efficient regulation. Fox-1/Fox-2 proteins, potent regulators of alternative splicing in the heart, skeletal muscle, and brain, repress calcitonin-specific splicing of the calcitonin/CGRP pre-mRNA. Using biochemical analysis, we found that Fox-1/Fox-2 proteins block prespliceosome complex formation at two distinct steps through binding to two functionally important UGCAUG elements. First, Fox-1/Fox-2 proteins bind to the intronic site to inhibit SF1-dependent E′ complex formation. Second, these proteins bind to the exonic site to block the transition of E′ complex that escaped the control of the intronic site to E complex. These studies provide evidence for the first example of regulated E′ complex formation. The two-step repression of presplicing complexes by a single regulator provides a powerful and accurate regulatory strategy.

Pharmaceutical Innovation in the United States: Factors Affecting Future Performance

1993 ◽  
Vol 9 (2) ◽  
pp. 167-173 ◽  
Author(s):  
Michael R. Pollard
Keyword(s):  
United States ◽  
Pharmaceutical Industry ◽  
Research And Development ◽  
Cost Containment ◽  
The United States ◽  
Private Companies ◽  
Factors Affecting ◽  
The Past ◽  
Future Performance ◽  
Regulatory Strategy

AbstractFueled by high returns on its investments, the pharmaceutical industry in the United States has flourished for the past 50 years. The regulatory strategy of demanding stringent testing then allowing market-based pricing has allowed private companies to fund ambitious research and development activities with the assurance that these investments will be recovered. However, aggressive managed-care cost-containment strategies threaten the companies' ability to recoup research and development expenses and may affect their willingness to invest in future innovative research.

scholarly journals Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations

2021 ◽  
pp. 191-205
Author(s):  
Michelle Crouthamel ◽  
Robert J. Mather ◽  
Suraj Ramachandran ◽  
Kai Bode ◽  
Godhuli Chatterjee ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Drug Development ◽  
Sleep Disturbances ◽  
Digital Health ◽  
The Novel ◽  
Tool Selection ◽  
Health Technologies ◽  
Study Approach ◽  
Digital Medicine ◽  
Regulatory Strategy

The development of novel digital endpoints (NDEs) using digital health technologies (DHTs) may provide opportunities to transform drug development. It requires a multidisciplinary, multi-study approach with strategic planning and a regulatory-guided pathway to achieve regulatory and clinical acceptance. Many NDEs have been explored; however, success has been limited. To advance industry use of NDEs to support drug development, we outline a theoretical, methodological study as a use-case proposal to describe the process and considerations when developing and obtaining regulatory acceptance for an NDE to assess sleep in patients with rheumatoid arthritis (RA). RA patients often suffer joint pain, fatigue, and sleep disturbances (SDs). Although many researchers have investigated the mobility of joint functions using wearable technologies, the research of SD in RA has been limited due to the availability of suitable technologies. We proposed measuring the improvement of sleep as the novel endpoint for an anti-TNF therapy and described the meaningfulness of the measure, considerations of tool selection, and the design of clinical validation. The recommendations from the FDA patient-focused drug development guidance, the Clinical Trials Transformation Initiative (CTTI) pathway for developing novel endpoints from DHTs, and the V3 framework developed by the Digital Medicine Society (DiMe) have been incorporated in the proposal. Regulatory strategy and engagement pathways are also discussed.

scholarly journals Recent drug regulatory affair and CTD module progress review for submission of pharmaceuticals product

2021 ◽  
Vol 16 (3) ◽  
pp. 200-221
Author(s):  
Vaibhav Subhash Janjal ◽  
Snehal Ramdas Dhamodkar ◽  
Yogesh Pralhad Jadhao ◽  
Sima Baburao Manmode ◽  
Anil Keshav Pawar ◽  
...  
Keyword(s):  
Drug Approval ◽  
Regulatory Elements ◽  
Product Management ◽  
Complementary Medicines ◽  
Regulatory Affairs ◽  
Emerging Trends ◽  
Regulatory Strategy ◽  
Regulatory Bodies ◽  
Drug Approval Process ◽  
Pharmacy Curriculum

Regulatory Affairs (RA), also known as government affairs, is a relatively new profession that arose from governments' desire to protect public health by regulating the safety and efficacy of products such as pharmaceuticals, medical devices, pesticides, veterinary medicines, cosmetics, agrochemicals, and complementary medicines. Pharmaceutical regulatory affairs is concerned with the registration of pharmaceutical goods. All regulatory elements and guidelines connected to product filing are summarized in this evaluation. This study covers the whole CTD and eCTD submission process, as well as the modules that go with it. It also focuses on the key regulatory bodies across the world. Various roles of DRA departments, drug regulatory affairs professionals, the importance of drug affairs in pharmacy curriculum, emerging trends affecting regulatory strategy, regulatory affairs in product management, clinical trials, R&D and the drug approval process in the US, EU, and ROW market trends are discussed.

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