scholarly journals Impact of a US Food and Drug Administration Drug Safety Communication on Zolpidem Dosing

2015 ◽  
Author(s):  
Jonathan L. Harward ◽  
Valerie B. Clinard ◽  
Michael R. Jiroutek ◽  
Beverly H. Lingerfeldt ◽  
Andrew J. Muzyk
Keyword(s):  
Drug Administration ◽  
Drug Safety ◽  
Food And Drug Administration ◽  
Safety Communication

scholarly journals Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

2017 ◽  
Vol 14 (3) ◽  
pp. 225-233 ◽  
Author(s):  
Raymond Perez ◽  
Patrick Archdeacon ◽  
Nancy Roach ◽  
Robert Goodwin ◽  
Jonathan Jarow ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Safety ◽  
Drug Administration ◽  
Drug Safety ◽  
Food And Drug Administration ◽  
Educational Materials ◽  
Research Staff ◽  
Safety Reporting ◽  
New Drug ◽  
Final Rule

Background/aims: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. Methods: In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative–nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. Results: The investigative site’s responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors’“filtering” of reports and increased sponsor communication. Sponsors replied that their greatest challenges include (1) lack of global harmonization in reporting rules, (2) determining causality, and (3) fear of regulatory repercussions. Interaction with the Food and Drug Administration has helped improve sponsors’ adherence to the final rule, and sponsors would benefit from increased communication with the Food and Drug Administration and educational materials. Conclusion: The goal of the final rule is to minimize uninformative safety reports so that important safety signals can be captured and communicated early enough in a clinical program to make changes that help ensure patient safety. Investigative staff and sponsors acknowledge that the rule has not been fully implemented although they agree with the intention. Clinical Trials Transformation Initiative will use the results from the surveys and interviews to develop new recommendations and educational materials that will be available to sponsors to increase compliance with the final rule and facilitate discussion between sponsors, investigators, and Food and Drug Administration representatives.

scholarly journals OP0237 THROMBOEMBOLIC SAFETY PROFILE OF TOFACITINIB AND BARICITINIB: AN ANALYSIS OF WHO VIGIBASE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 150.1-150
Author(s):  
E. Vallejo-Yagüe ◽  
S. Weiler ◽  
A. M. Burden
Keyword(s):  
Rheumatoid Arthritis ◽  
High Risk ◽  
Drug Administration ◽  
Drug Safety ◽  
Food And Drug Administration ◽  
Jak Inhibitors ◽  
Global Database ◽  
Link Type ◽  
Blood Clots ◽  
The Us

Background:The Janus Kinase (JAK) inhibitors tofacitinib and baricitinib are new targeted treatments for rheumatoid arthritis. Recent concerns regarding the risk of thrombosis have led to warnings by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA)1,2.Objectives:To examine the safety reporting of tofacitinib and baricitinib, with focus on thromboembolic events.Methods:Individual case safety reports (ICSRs) for tofacitinib and baricitinib were retrieved from the World Health Organization (WHO) global database (VigiBase) in April 2019. The primary outcomes were deep vein thrombosis (DVT) and pulmonary thrombosis (PT) or pulmonary embolism (PE). A disproportionality analysis was conducted by estimating the reporting odds ratio (ROR) and 95% confidence intervals (CIs) to compare the observed versus expected reporting ratio of DVT or PT|PE for tofacitinib or baricitinib. The ROR were calculated worldwide and stratifying by reporting from Europe or the US. In a secondary analysis, further thrombotic-related outcomes were investigated.Results:In both tofacitinib (n=40,017) and baricitinib (n=2,138) ICSRs, patients with reported DVT or PT|PE were older and had higher reporting of pro-thrombotic medications (e.g., contraceptives) or indicators of thromboembolic risk (i.e., antithrombotic treatment). The use of tofacitinib was associated with a significant increased reporting for DVT (ROR: 2.37 95% CI 1.23-4.56) and PT|PE (ROR 2.38 95% CI 1.45-3.89) in Europe. In the US, tofacitinib was only associated with an elevated reporting of PT (ROR: 2.05 % CI 1.45-2.90). Baricitinib was associated with a 3-fold increased risk of reporting for DVT (ROR: 3.47 95% CI 2.18-5.52) or PT|PE (ROR: 3.44 95% CI 2.43-4.88) in Europe, which accounted for 97% of all baricitinib ICSRs. Secondary thrombotic-related outcomes were poorly reported overall in VigiBase.Conclusion:This study supports the cautious use of JAK inhibitors in patients with rheumatoid arthritis who have a high thrombotic risk profile. Moreover, a potential class effect of JAK inhibitors cannot be ruled out.References:[1]FDA Drug Safety Communication. Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate. Food and Drug Administration (FDA)http://www.fda.gov/drugs/drug-safety-and-availability/safety-trial-finds-risk-blood-clots-lungs-and-death-higher-dose-tofacitinib-xeljanz-xeljanz-xr(2019).[2]EMA confirms Xeljanz to be used with caution in patients at high risk of blood clots. EMA/608520/2019.https://www.ema.europa.eu/en/documents/referral/xeljanz-article-20-procedure-ema-confirms-xeljanz-be-used-caution-patients-high-risk-blood-clots_en.pdf(2019).Acknowledgments:We are thankful to every pharmacovigilance centre and contributor to the WHO Programme for International Drug Monitoring and VigiBase.While the authors used data from the VigiBase, the WHO global database of ICSRs as a source of information, the conclusions do not represent the opinion of the Uppsala Monitoring Centre (UMC) or the WHO.Disclosure of Interests:Enriqueta Vallejo-Yagüe Employee of: Synovo GmbH 2012-2018 (not related to this abstract), Stefan Weiler Consultant of: Gedeon-Richter for drug safety 2017 (not related to this abstract), Andrea Michelle Burden: None declared

scholarly journals Comparison of Medical Device Regulations in India, Japan and South Korea

2021 ◽  
pp. 8-23
Author(s):  
Chandan B. V. ◽  
M. P. Venkatesh ◽  
Arjun M. ◽  
Pasupuleti Dheeraj Krishna ◽  
Indraprasad S.
Keyword(s):  
South Korea ◽  
Medical Device ◽  
Drug Administration ◽  
Drug Safety ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Asia Pacific ◽  
The South ◽  
South Korean ◽  
Medical Devices Act

Increased health awareness, a growing middle class, and government health efforts are projected to propel India's medical equipment market forward in the next years. With the publication of the Medical Device Rules in 2017, Indian authorities revised the medical device regulatory process. The devices included in the link are currently regulated medical devices and in vitro diagnostic devices, as well as their classifications. CLA (Central Licensing Authority) is in charge of all import device licencing, as well as manufacturing, loan, and wholesale licences for Class C and Class D medical devices. Because of its complicated registration process and linguistic obstacles, Japan is regarded one of the most difficult markets for overseas medical device producers. The Pharmaceutical and Medical Device Agency, which works in tandem with the MHLW (Ministry of Health and Labour Welfare), is in charge of reviewing drug and medical device applications in Japan. The Pharmaceuticals and Medical Devices Act is a federal law that regulates the sale of pharmaceuticals and medical devices. The Pharmaceuticals and Medical Devices Act, also known as the Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics, lays out the current PMDA (Pharmaceuticals and Medical devices Agency) laws in Japan. South Korea is one of the largest health-care markets in the Asia-Pacific region. Medical Devices in South Korea are regulated by the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA). Medical Devices in South Korea are regulated by the Ministry of Food and Drug Safety, formerly known as the Korea Food and Drug Administration. The Medical Device Act of 2015 governs current medical device laws in Korea. To access the South Korean Medical-Device-Market, you must first obtain marketing approval from the local Medical Device Authority, the Medical Device Information & Technology Centre, which is part of the Ministry of Food and Drug Safety. With the MFDS notification No. 2020-29, the South Korean Ministry of Food and Drug Safety launched UDI (Unique Device Identification System) operations in 2018. Article 20 of the Medical Device Act and Article 54-2 of the Medical Device Act Enforcement Regulations make UDI compliance mandatory.

Impact of the Food and Drug Administration Safety Communication on the Use of Power Morcellator in Daily Clinical Practice: An Italian Survey

2016 ◽  
Vol 23 (2) ◽  
pp. 206-214 ◽  
Author(s):  
Vincenzo Dario Mandato ◽  
Federica Torricelli ◽  
Debora Pirillo ◽  
Lorenzo Aguzzoli ◽  
Martino Abrate ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Daily Clinical Practice ◽  
Safety Communication ◽  
Italian Survey

scholarly journals Is the Food and Drug Administration Safe and Effective?

2008 ◽  
Vol 22 (1) ◽  
pp. 85-102 ◽  
Author(s):  
Tomas J Philipson ◽  
Eric Sun
Keyword(s):  
Drug Administration ◽  
Drug Safety ◽  
Food And Drug Administration ◽  
Product Liability ◽  
The United States ◽  
Liability Law ◽  
Life Saving ◽  
Prescription Drug User ◽  
Before And After ◽  
Future Work

In the United States, the Food and Drug Administration (FDA) provides public oversight of the safety and efficacy of drugs; medical devices; biologics like vaccines and blood products; cosmetics; radiation-emitting electronic products; veterinary products; and all foods, except meat and poultry (which are regulated by the Department of Agriculture). According to the FDA, the products it regulates account for more than one-fifth of U.S. consumer spending. In the area of medical products, the FDA is responsible for determining whether marketed products are both safe and effective before and after they have been marketed. In this paper, we will explore whether the policies of the agency itself are safe and effective. We stress two issues, one static and one dynamic. The static issue concerns the potential duplication inefficiency when product safety is protected not only by the FDA but also by the private sector through product liability law. Put another way, what is the rationale for using product liability and the FDA to regulate drug safety? While intuitively it may seem that two systems must be better than one in ensuring drug safety, each system comes with costs. We then turn to the dynamic issue, the speed–safety trade off, and consider the extent to which higher safety is achieved at a cost of later market entry of effective and even life-saving products. We assess the Prescription Drug User Fee Acts (PDUFAs), which increased the speed of the agency's regulatory process starting in 1992, although according to some, at the cost of reducing drug safety. We conclude by suggesting a research agenda for future work on the Food and Drug Administration.

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