Analysis of FDA Warning Letters Issued to Indian Pharmaceutical and Medical Device Companies: A Retrospective Study

2019 ◽  
pp. 216847901987938
Author(s):  
Shray Bablani ◽  
Manthan D. Janodia
Keyword(s):  
Retrospective Study ◽  
Medical Device ◽  
Pharmaceutical Products ◽  
Pharmaceutical Companies ◽  
Federal Regulations ◽  
Public Database ◽  
Pharmaceutical Manufacturers ◽  
Medical Device Manufacturers ◽  
Corrective Actions

Background: FDA issues warning letters to pharmaceutical manufacturers, distributors, or clinical investigators if it observes serious violations of federal regulations. These warning letters contain the details about the nature of the violations observed and the corrective actions recommended by the FDA. A follow-up inspection may be requested by the recipient after taking the corrective actions. Methods: Analysis of warning letters issued to Indian pharmaceutical companies from January 1, 2005, to December 31, 2018, was carried out. The warning letters were extracted from FDA’s public database. Results: Across the 14-year study period, the number of warning letters issued to Indian pharmaceutical and medical device manufacturers has gradually increased. Of all the violations listed in these warning letters, 85.87% were related to the failure of compliance with the cGMP guidelines. Moreover, 80.72% of these warning letters were not followed by a close-out warning, which indicated that the violations listed in these warning letters could not be resolved. Conclusion: As the inability of the recipients to comply with the cGMP guidelines formed the majority of the violations observed in the warning letters, more resources and manpower have to be assigned to the manufacturing process of the pharmaceutical products.

scholarly journals Cure for Empire: The ‘Conquer-Russia-Pill’, Pharmaceutical Manufacturers, and the Making of Patriotic Japanese, 1904–45

2013 ◽  
Vol 57 (2) ◽  
pp. 249-268 ◽  
Author(s):  
Hoi-eun Kim
Keyword(s):  
Public Opinion ◽  
International Relations ◽  
Pharmaceutical Products ◽  
Consumer Response ◽  
The State ◽  
Pharmaceutical Companies ◽  
Top Down ◽  
The Public ◽  
Pharmaceutical Manufacturers ◽  
The Matrix

AbstractSeirogan, a popular anti-diarrhoeal pill, is arguably one of the most successful pharmaceutical products of modern Japan. What is less known is that the Japanese army initially developedSeiroganduring the Russo-Japanese War as the ‘Conquer-Russia-Pill’, which was later marketed to the public by private manufacturers. Previous scholars have emphasised the top–down governmental method of mobilising private sectors to manipulate public opinion for the cause of external imperialist expansion and domestic stability during wartime Japan. But the matrix that the Conquer-Russia-Pill allows us to glimpse is an inverted power relation among the state, commercial sectors, and imperial citizens. While the Japanese government remained indifferent if not hostile to jingoistic pharmaceutical manufacturers who could easily disrupt international relations, pharmaceutical companies quickly recognised and exploited the opportunities that the Conquer-Russia-Pill and its symbolism provided under the banner of the empire. In turn, Japanese consumers reacted to commercial sermons carefully anchored in patriotic and militaristic discourses and images by opening their wallets. In other words, the popularity of the Conquer-Russia-Pill was a culmination of the convergence of a governmental initiative to enhance military capabilities, the commercial ingenuity of pharmaceutical manufacturers, and a consumer response to patriotic exhortations.

scholarly journals Process Surveillance and Follow-Up Monitoring to Increase Compliance to Standards in Medical Device Reprocessing

2020 ◽  
Vol 41 (S1) ◽  
pp. s360-s360
Author(s):  
Mark Scott ◽  
Sharon Wilson ◽  
Kathryn Bush ◽  
Control ◽  
Karin Fluet ◽  
...  
Keyword(s):  
Patient Safety ◽  
Health Services ◽  
Health System ◽  
Medical Device ◽  
Review Process ◽  
Resolution Rate ◽  
Physical Infrastructure ◽  
Corrective Actions ◽  
Medical Device Reprocessing

Background: Effective medical device reprocessing (MDR) is essential in preventing the spread of microorganisms and maintaining patient safety. Alberta Health Services (AHS) is an Alberta-wide, integrated health system, responsible for delivering health services to >4.3 million people living in the province. In 2010, periodic province-wide MDR reviews were initiated by the provincial health system to verify that the cleaning, disinfection, and sterilization of reusable critical and semicritical medical devices met established standards. To date, there have been 3 review cycles; in cycle 3, a follow-up process for tracking and reporting corrective actions was initiated. Methods: As in previous MDR review cycles, cycle 3 included the use of a standardized suite of tools to measure compliance with standards set by Accreditation Canada, the Canadian Standards Association, and the Government of Alberta. Each cycle involved a review of MDR areas completed by trained reviewers. Interrater reliability among reviewers was maintained through training and debriefings following reviews to ensure agreement. Following reviews, reports were generated for areas, zones, and AHS. As part of the corrective actions and follow-up process, identified deficiencies were categorized into 5 themes. Corrective actions were tracked and periodic reports were generated showing the progress of deficiency resolution. Resolution rates (number of resolved deficiencies divided by total number of of deficiencies) were calculated for each of the identified themes as well as overall for cycle 3. Results: Overall compliance for cycle 3 was 93%. Cycle 3 reviews revealed that more than half of the deficiencies (58%) were identified previously in cycle 2. The resolution rates ranged from 78% to 95% for identified deficiencies for 4 of the 5 themes: documentation, technique, PPE/attire/hand hygiene, and other. The theme related to physical infrastructure showed a considerably lower resolution rate of 49%. The corrective action follow-up process showed increased overall resolution rate from 59% at the start of the follow-up process to 82% at its completion. When this resolution rate was applied to the initial survey compliance rate for cycle 3, overall compliance increased to 99%. Conclusions: Monitoring quality of MDR practices is essential in maintaining and improving patient safety. The standardized provincial review process identified common themes and a coordinated approach to support the resolution of many identified deficiencies. Most of those deficiencies were resolved; however, those deficiencies related to physical infrastructure of the MDR department continue to be seen across review cycles. This review process with follow up of these deficiencies can help bring attention to organization leadership and Funding: authorities during budget cycles.Funding: NoneDisclosures: None

Marketing Health Care Products on the Internet: A Proposal for Updated Federal Regulations

1998 ◽  
Vol 24 (2-3) ◽  
pp. 365-386
Author(s):  
Kristen Green
Keyword(s):  
Health Care ◽  
Medical Device ◽  
Information Disclosure ◽  
Web Search ◽  
The Internet ◽  
Pharmaceutical Companies ◽  
Web Pages ◽  
Interactive Marketing ◽  
Disclosure Requirements ◽  
Medical Device Manufacturers

The Internet offers pharmaceutical companies and medical device manufacturers a dynamic new medium for promoting their products—a medium that might actually be better suited for health care product promotion than print or television. On the Internet's World Wide Web (Web) pages, drug and device makers can produce interactive marketing and advertising material that more easily complies with current Food and Drug Administration (FDA) and Federal Trade Commission (FTC) disclosure requirements. Navigation buttons and hypertext links can facilitate compliance with such information disclosure requirements by allowing drug and device makers to “hide” the brief summaries or labels until interested viewers “click” on them.Despite the appropriateness of the medium, however, a Web search today will turn up less drug and medical device promotion than one might expect. In fact, the Web, which represented $7 billion in commerce in 1997 and is expected to account for $20 billion in 1998, is strangely quiet on this front.

Relationship between Cross-Border Mergers and Acquisitions and International Trade: The Case of Russian Pharmaceutical Industry

2020 ◽  
pp. 81-94
Author(s):  
Alexandra V. Chugunova ◽  
Olga A. Klochko
Keyword(s):  
International Trade ◽  
Mergers And Acquisitions ◽  
Volume Growth ◽  
Pharmaceutical Products ◽  
Pharmaceutical Companies ◽  
Cross Border ◽  
Export Volume ◽  
Relationship Of ◽  
Geographical Diversification ◽  
The Relationship

This research studies the relationship of cross-border mergers and acquisitions to international trade through the lens of Russian pharmaceutical market. To this aim, the study analyses the woks of foreign economists dedicated to evaluating the link between foreign direct investment and international trade, and the influence of mergers and acquisitions on countries’ export and import flows. The research also presents a correlation analysis between the volume of Russian pharmaceutical exports and imports and cross-border deals performed by foreign pharmaceutical companies in Russia. We characterize these deals and conduct a comparative analysis of the regional structure of Russian pharmaceutical exports and imports as well as of the countries of origin of buyers in cross-border mergers and acquisitions. The results of the analysis indicate a positive relationship between cross-border mergers and acquisitions and Russian pharmaceutical exports, which is reflected in the export volume growth and its geographical diversification. However, it is outlined that particular problems of the industry hinder the amelioration of Russian positions in international exports. Similarly, the relationship between cross-border deals and Russian imports is positive: the major pharmaceutical products supply flow occurs from the countries of origin of buyers in cross-border mergers and acquisitions conducted in the Russian pharmaceutical sector.

Comparative analysis of business models of top pharmaceutical manufacturing companies: fifi nancial analysis

2020 ◽  
pp. 43-52
Author(s):  
L.E. Yasinskaya ◽  
Keyword(s):  
Comparative Analysis ◽  
Business Models ◽  
Financial Analysis ◽  
Active Pharmaceutical Ingredient ◽  
Pharmaceutical Companies ◽  
Manufacturing Companies ◽  
Revenue Growth ◽  
Commercial Activities ◽  
Pharmaceutical Manufacturers ◽  
Research Procedure

Introduction. Earlier, the comparative analysis of the commercial and investment activities of the companies that play the key roles in the investment processes in the Russian pharmaceutical industry and operate within the four main business models (biotechnological, generic, specialized pharmaceutical companies, active pharmaceutical ingredient (API) manufacturers) has been conducted. No full assessment of the companies’ activitiesis conceivable without a financial analysis of their activities to identify the risks of investment activities. Objective of the study. A detailed comparative analysis of the financial standing of domestic pharmaceutical manufacturers operating within the selected business models for further identification of potential financial risks for investors. Research procedure and article structure. Analysis of RAS statements (forms 1 and 2) of 72 over 500 million revenue companies grouped together as selected business models for the period from 2015 to 2019. Results. The researchers provided a detailed description of the commercial activities of domestic pharmaceutical companies within the business models under consideration. The companies within various business models showed positive revenue growth rates over the past five years. All business models demonstrate consistently high business profitability and a significant share of own capital in the asset profile. Conclusion. The results of the study show the stable financial standing of the pharmaceutical companies within various business models. The biotechnology sector companies that are the most attractive for investments have the highest quality financial standing. The specialized and generic companies show similar consistently strong performance. API manufacturers that the companies with relatively small revenues are actively developing and are attractive to restrained budget investors.

Clinical Value of Computer-Assisted Taylor Three-dimensional External Fixation in the Treatment of Tibiofibular Fracture (Preprint)

2020 ◽  
Author(s):  
Hongfeng Sheng ◽  
Weixing Xu ◽  
Bin Xu ◽  
Hongpu Song ◽  
Di Lu ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Internal Fixation ◽  
External Fixation ◽  
External Fixator ◽  
Theoretical Basis ◽  
New Technology ◽  
Three Dimensional ◽  
Computer Assisted ◽  
Clinical Value

UNSTRUCTURED The retrospective study of Taylor's three-dimensional external fixator for the treatment of tibiofibular fractures provides a theoretical basis for the application of this technology. The paper collected 28 patients with tibiofibular fractures from the Department of Orthopaedics in our hospital from March 2015 to June 2018. After the treatment, the follow-up evaluation of Taylor's three-dimensional external fixator for the treatment of tibiofibular fractures and concurrency the incidence of the disease, as well as the efficacy and occurrence of the internal fixation of the treatment of tibial fractures in our hospital. The results showed that Taylor's three-dimensional external fixator was superior to orthopaedics in the treatment of tibiofibular fractures in terms of efficacy and complications. To this end, the thesis research can be concluded as follows: Taylor three-dimensional external fixation in the treatment of tibiofibular fractures is more effective, and the incidence of occurrence is low, is a new technology for the treatment of tibiofibular fractures, it is worthy of clinical promotion.

Hand eczema patients’ knowledge of skin protection following a guided talk—A retrospective study with a follow‐up questionnaire

2019 ◽  
Vol 81 (2) ◽  
pp. 117-123 ◽  
Author(s):  
Yasemin Topal ◽  
Tove Agner ◽  
Janique van der Heiden ◽  
Niels E. Ebbehøj ◽  
Kim K. B. Clemmensen
Keyword(s):  
Retrospective Study ◽  
Hand Eczema ◽  
Skin Protection
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