Voicing regulatory perspectives of the combination products

2020 ◽  
Vol 16 (3) ◽  
pp. 101-111
Author(s):  
Sumit Sanduria ◽  
Swagat Tripathy ◽  
PN Murthy ◽  
BP Patra ◽  
Harish Dureja
Keyword(s):  
Regulatory Agency ◽  
Chronic Condition ◽  
Regulatory Regime ◽  
Combination Product ◽  
Biological Product ◽  
Medical Products ◽  
Regulatory Submission ◽  
Review Period ◽  
Acute Condition ◽  
Key Aspects

Combination products (CPs) are nothing but medical products that do not adequately apt solely into a regulatory category, but reasonably comprise of any combination of drug, device and biological product. The use of combination products and delivery systems are to deal with a chronic condition or to relieve an acute condition or to treat the various lives threaten & complex diseases. This article assesses the regulation of combination products in USA, India, China, Japan and Europe and likens the regulatory regime in pharmaceutical environments. Though many of these types of products have been available for years, recent FDA guidelines have spelled out viewpoint on both a development and commercialization perspective. These elucidations have led to augment regulatory expectations resulting in new and increased challenges. To make sure compliance with these regulations and beat challenges, it is essential to remain familiar with the dynamic changing regulations. This piece of writing spotlights on key aspects to understand the concept of combination products, its classification, review period and most importantly facts to consider when any organization is gearing up for a regulatory submission to regulatory agency and its prospective for PLCM of the combination product.

Paraphimosis revisited: is chronic paraphimosis a predominantly third world condition?

2008 ◽  
Vol 38 (1) ◽  
pp. 40-42 ◽  
Author(s):  
M Rangarajan ◽  
S M Jayakar
Keyword(s):  
Chronic Condition ◽  
Third World ◽  
New Classification ◽  
The Third ◽  
Long Term Follow Up ◽  
Initial Injury ◽  
Acute Condition

Paraphimosis is an acute condition characterized by all the signs of inflammation. Here we describe a ‘chronic’ variant of paraphimosis where patients often present many days after the initial injury. The aim of this study is to identify and possibly classify this new variation of paraphimosis – the chronic condition. We studied 68 patients with this condition between 1997 and 2005. In all, the prepuce was fibrous and bunched up behind the glans penis and, in some cases, with ulcerations. All patients were treated by excision of the fibrous flap and circumcision, under local anaesthesia. Patients were discharged on the same dayon which the excision was done. Follow-up was on the third, seventh and ninetieth days. Long-term follow-up was possible in only 22 patients. This technique of modified circumcision was effective in treating this condition and we think a new classification of paraphimosis is warranted – acute and chronic.

scholarly journals Biosimilar medical products – licensing, pharmacovigilance and interchangeability

PRILOZI ◽  
2016 ◽  
Vol 37 (1) ◽  
pp. 27-36 ◽  
Author(s):  
Aleksandra Grozdanova ◽  
Katerina Ancevska Netkovska ◽  
Zoran Sterjev ◽  
Zorica Naumovska ◽  
Rubin Zarevski ◽  
...  
Keyword(s):  
Generic Version ◽  
Financial Sustainability ◽  
Clinical Use ◽  
Patient Access ◽  
Biological Product ◽  
Regulatory Requirements ◽  
Complex Molecules ◽  
Medical Products ◽  
Biological Medicine ◽  
Improve Patient

Abstract The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies in many diseases. The expiration of patents of biological innovative medicines enables copies of those drugs called similar biological products (biosimilars) to be approved by regulatory authorities and to enter in clinical use. Biosimilars are comparable but not identical and are not a generic version of the innovator biological product. Although biosimilars undergo rigorous characterization as well as clinical studies to prove their safety and effectiveness, specific regulatory requirements for registration apply in the case of biosimilars. They are highly complex molecules and small changes in the production process can have major implications in its safety and effectiveness profile. The availability of biosimilars enhances competition, with the potential to improve patient access to biological medicines and to contribute to the financial sustainability of healthcare systems. In order to be certain that a biosimilar reaches its potential in clinical use, an intensive pharmacovigilance monitoring system must be established in order to prove the true similarity between the original biologic and its biosimilar. There is a need for further guidance and resolution of the ongoing discussions on biosimilar labelling, naming, pharmacovigilance and substitution in order to ensure effective and appropriate use of biosimilars in clinical practice.

scholarly journals A Critical Analysis of the Delivery of a Psychosocial Workshop for Cancer Survivors with Lymphedema

2018 ◽  
Author(s):  
Ryan Hamilton ◽  
Roanne Thomas ◽  
Yvonne Anisimowicz ◽  
Marquelle Piers ◽  
Renee Matte
Keyword(s):  
Critical Analysis ◽  
Chronic Condition ◽  
Safe Space ◽  
Central Theme ◽  
Secondary Lymphedema ◽  
Safe Environment ◽  
Social Impairments ◽  
Future Workshop ◽  
Key Aspects ◽  
And Coping

Secondary lymphedema is a chronic condition that can develop after the treatment of cancer and can often lead to negative psychological and social impairments. When dealing with chronic illness, hoping and coping are interdependent. Previous research has assessed the outcomes of workshops designed to enhance hope but has not examined the workshop itself to determine how those outcomes were achieved. This study deconstructs the Living Hopefully with Lymphedema workshop to identify (1) what aspects of the workshop facilitated or interfered with therapeutic progress, (2) key aspects of facilitation that contributed to the functioning of the workshop, and (3) how participants responded to the workshop. Two three-day workshops were attended by a total of 19 participants. All sessions were audio taped and the recordings analyzed. Theoretical coding revealed a central theme focused on the importance of a safe environment within the workshop. Facilitators and participants worked together to co-create, maintain, and protect a safe space in which to engage in therapy. Findings are discussed in relation to key aspects of facilitation and the participants’ response to the workshops. Recommendations for future workshop development are presented.

scholarly journals Astrocytic Response to Acutely- and Chronically-Implanted Microelectrode Arrays in the Marmoset (Callithrix jacchus) Brain

2019 ◽  
Vol 9 (2) ◽  
pp. 19 ◽  
Author(s):  
Samuel Budoff ◽  
Kim Yano ◽  
Fernanda de Mesquita ◽  
Jhulimar Doerl ◽  
Maxwell de Santana ◽  
...  
Keyword(s):  
Glial Fibrillary Acidic Protein ◽  
Chronic Condition ◽  
Microelectrode Arrays ◽  
Glial Scar ◽  
Electrode Impedance ◽  
Brain Machine Interfaces ◽  
Neuroscience Research ◽  
Brain Implants ◽  
Acute Condition ◽  
Over Time

Microelectrode implants are an important tool in neuroscience research and in developing brain–machine interfaces. Data from rodents have consistently shown that astrocytes are recruited to the area surrounding implants, forming a glial scar that increases electrode impedance and reduces chronic utility. However, studies in non-human primates are scarce, with none to date in marmosets. We used glial fibrillary acidic protein (GFAP) immunostaining to characterize the acute and chronic response of the marmoset brain to microelectrodes. By using densitometry, we showed that marmoset astrocytes surround brain implants and that a glial scar is formed over time, with significant increase in the chronic condition relative to the acute condition animal.

scholarly journals Good Practices in Management of deficiencies in CTD dossier and comparative study for US, EU and Australia

2019 ◽  
Vol 7 (4) ◽  
pp. 40-55
Author(s):  
Pooja Chaudhari ◽  
Jitendra Kumar Badjatya
Keyword(s):  
Comparative Study ◽  
Regulatory Agency ◽  
Development Process ◽  
Drug Product ◽  
Good Practices ◽  
Drug Products ◽  
Regulatory Submission ◽  
Market Authorization ◽  
Effective Role ◽  
Country Specific

This topic aims at reviewing the drug and drug product filing and obtaining USFDA EMEA and TGA approval and its effective role to improve the standards which are laid by them. The respective Regulatory Agency approves the new/generic drug products that govern respective market before introduction of particular product into the market. The Regulatory Agency approves the entire new drug product to be safe and effective before marketing. USFDA is the Regulatory Agency which is responsible for the regulation of food and drug product in USA. EMEA is the Regulatory Agency which is responsible for the regulation of food and drug product in Europe. TGA is the Regulatory Agency which is responsible for the regulation of therapeutic goods in Australia. A dossier contains detail information about the drug substance and drug product and result of studies that are carried out in development process. For getting market authorization has to be submitted to the respective regulation bodies. Due to various regulations, ICH introduced CTD for such countries that come under it. CTD is critical for dossier submission. For regulatory submission that is to be accepted in all ICH countries. CTD provides standardized structure. CTD makes filing easier globally. But there are differences in dossier submission requirements in these countries i.e. Module I is country specific and other regional guideline are also considered while compiling dossier application.

scholarly journals Products in a Pandemic: Liability for Medical Products and the Fight against COVID-19

2020 ◽  
Vol 11 (3) ◽  
pp. 565-603 ◽  
Author(s):  
Duncan FAIRGRIEVE ◽  
Peter FELDSCHREIBER ◽  
Geraint HOWELLS ◽  
Marcus PILGERSTORFER
Keyword(s):  
Product Liability ◽  
Legal Issues ◽  
Regulatory Regime ◽  
Protective Equipment ◽  
Products Liability ◽  
Medical Products ◽  
Fault Compensation ◽  
Alternative Responses ◽  
The Impact ◽  
European Product

A multitude of medical products are being developed and produced as part of efforts to tackle COVID-19. They are varied in nature and range from test kits to tracing apps, protective equipment, ventilators, medicines and, of course, vaccines. The design, testing and manufacture of many of these products differs from production in normal times due to the urgency of the situation and the rapid increase in demand created by the pandemic. This article considers the legal issues arising as a result of the production of emergency products, particularly from a products liability perspective. To what extent do existing concepts under the European Product Liability Directive, such as defect, causation and the various defences, permit the pandemic to be taken into account when a Court is considering issues of liability? What is the impact on liability of the modified regulatory regime? In light of that discussion, the case for alternative responses is examined from a comparative and European perspective, including the issue of Government indemnities for the manufacturers of products, legal exemptions from liability and alternative no-fault compensation schemes.

Strict Liability for Medical Products: Prospects for Success

2002 ◽  
Vol 5 (4) ◽  
pp. 281-304
Author(s):  
Shanti Williamson
Keyword(s):  
Strict Liability ◽  
Product Liability ◽  
Case Law ◽  
Medical Product ◽  
Judicial Interpretation ◽  
Medical Products ◽  
Consumer Protection Act ◽  
The United Kingdom ◽  
First Case ◽  
Key Aspects

The premise of product liability reform has been that strict, rather than fault based liability, is the most equitable means of compensating personal injuries. The movement for reform was instigated, in part, by the tragedy of Thalidomide. The difficulties faced by claimants seeking compensation in negligence were substantial, especially in respect of claims involving medical products. The introduction of a regime of strict liability by Directive 85/374/EEC, and its implementation in the United Kingdom by Part I of the Consumer Protection Act 1987, were intended to ameliorate some of these difficulties. The extent to which the regime accomplishes this has been a matter of speculation. Recent case law, however, provides much needed judicial interpretation of key aspects of the regime. The case of A and others v National Blood Authority and another makes a significant contribution to case law, and is, notably, the first case to succeed against the producer of a medical product. There is now reason to believe that the strict liability regime affords claimants, especially in cases involving medical products, advantages compared to negligence. However, some aspects remain unclear, and some difficulties, particularly affecting medical products, persist. It may be that further reform is necessary, to achieve greater certainty and to enhance the prospects for successful claims in this area.

Web-Based Financial Reporting: An Interpretative Model for Corporate Communications on Social Media

2017 ◽  
pp. 79-112
Author(s):  
Paola Ramassa ◽  
Costanza Di Fabio
Keyword(s):  
Social Media ◽  
Financial Reporting ◽  
Building Blocks ◽  
Corporate Communications ◽  
Distinctive Features ◽  
Financial Communication ◽  
Use Of Social Media ◽  
Key Aspects ◽  
And Diffusion ◽  
Interpretative Model

This paper aims at contributing to financial reporting literature by proposing a conceptual interpretative model to analyse the corporate use of social media for financial communication purposes. In this perspective, the FIRE model provides a framework to study social media shifting the focus on the distinctive features that might enhance web investor relations. The model highlights these features through four building blocks: (i) firm identity (F); (ii) information posting (I); (iii) reputation (R); and (iv) exchange and diffusion (E). They represent key aspects to explore corporate communication activities and might offer a framework to interpret to what degree corporate web financial reporting exploits the potential of social media. Accordingly, the paper proposes metrics based on this model aimed at capturing the interactivity of corporate communications via social media, with a particular focus on web financial reporting. It tries to show the potential of this model by illustrating an exploratory empirical analysis investigating to what extent companies use social media for financial reporting purposes and whether firms are taking advantage of Twitter distinctive features of interaction and diffusion.

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