N of 1 Data Sharing: The Impact of Data Sharing within the Hematology–Oncology Drug Products Division of the US FDA

2021 ◽  
Author(s):  
Jennifer Gill ◽  
Vinay Prasad
Keyword(s):  
Data Sharing ◽  
Drug Products ◽  
Oncology Drug ◽  
The Us ◽  
Us Fda ◽  
The Impact

scholarly journals Abuse-deterrent opioid analgesics: a guide for clinicians

2020 ◽  
Vol 10 (1) ◽  
pp. 55-62 ◽  
Author(s):  
Adam J Carinci
Keyword(s):  
Real World ◽  
Opioid Analgesics ◽  
Prescription Opioid ◽  
Pharmacokinetic Studies ◽  
Regulatory Issues ◽  
The Us ◽  
Us Fda ◽  
The Impact ◽  
Prescription Opioid Abuse

The US FDA has encouraged the development of abuse-deterrent formulations (ADFs) of opioid analgesics as one component in a comprehensive effort to combat prescription opioid abuse. Guidance issued by the FDA outlines three types of premarket studies for evaluating abuse deterrence: laboratory-based in vitro manipulation and extraction studies, pharmacokinetic studies and human abuse potential studies. After approval, postmarket studies are needed to evaluate the impact of an ADF product on abuse in real-world settings. This review summarizes the regulatory issues involved in the development of ADF opioids and clarifies abuse-deterrence claims in product labels, in order to assist clinicians in critically evaluating the available evidence pertaining to the abuse-deterrent features of opioid analgesics.

scholarly journals The Impact of Animal Agriculture on Human Health

2021 ◽  
Author(s):  
Andrea Kassay
Keyword(s):  
Antibiotic Resistance ◽  
Infectious Diseases ◽  
Health Problems ◽  
Human Diseases ◽  
Meat Industry ◽  
Animal Agriculture ◽  
The Us ◽  
Excessive Consumption ◽  
Us Fda ◽  
The Impact

Animal agriculture contributes to many health problems that exist today, such as the spread of infectious diseases, antibiotic resistance, and chronic human diseases like heart disease and cancer. With regards to infectious diseases, most modern day infections were unknown before the domestication of animals. Industrial agriculture forces a large number of genetically similar animals into unsanitary situations, providing the perfect conditions for viruses to emerge and spread to different species. With regards to antibiotic resistance, the US FDA estimates that each year, 80% of microbial drugs are sold to the meat industry. Countries that have the most microbial resistance also have the highest use of antimicrobials, such as penicillins, tetracyclines, and sulfonamides in animal agriculture. With regards to chronic human diseases, there is extensive evidence that the excessive consumption of animal-based products can lead to chronic diseases such as cardiovascular disease and some types of cancer. The purpose of this article is to further discuss how animal agriculture may be a cause of these current health problems and how adopting a plant-based diet can be a potential solution.

scholarly journals Daratumumab utilization and cost analysis among patients with multiple myeloma in a US community oncology setting

2021 ◽  
Author(s):  
Lucio N Gordan ◽  
Stanley M Marks ◽  
Mei Xue ◽  
Neil Nagovski ◽  
J Hunter Lambert ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Treatment Patterns ◽  
Cost Of Care ◽  
Dosing Schedule ◽  
Community Oncology ◽  
Improved Outcomes ◽  
The Us ◽  
Us Fda ◽  
The Cost ◽  
The Impact

Background: The introduction of daratumumab into the treatment of multiple myeloma has improved outcomes in patients; however, community oncologists often dose more frequently than the US FDA-approved label. Materials and methods: Integra analyzed its database to elucidate daratumumab treatment patterns and the impact of increased utilization on the cost of care for multiple myeloma. Results: Following week 24, 671 (65%) of 1037 patients remained on daratumumab-containing regimens, with 330 patients continuing more frequent treatments than the expected once-every-4-weeks dosing described in the standard dosing schedule. Patients received an average of 14% more daratumumab doses than the FDA-approved label indicates, increasing the 1-year daratumumab costs by an estimated US$31,353. Conclusion: Daratumumab is utilized more frequently than the FDA-recommended dosing, leading to higher multiple myeloma treatment costs.

scholarly journals Dark Clouds and Silver Linings: Impact of COVID-19 on Internet Users’ Privacy

JAMIA Open ◽  
2021 ◽  
Author(s):  
Ram D Gopal ◽  
Hooman Hidaji ◽  
Raymond A Patterson ◽  
Niam Yaraghi
Keyword(s):  
Data Sharing ◽  
Third Parties ◽  
Third Party ◽  
Latent Growth ◽  
Dark Clouds ◽  
Privacy Threats ◽  
Internet Users ◽  
The Us ◽  
User Data ◽  
The Impact

Abstract Objectives To examine the impact of COVID-19 pandemic on the extent of potential violations of Internet users’ privacy. Materials and Methods We conducted a longitudinal study of the data sharing practices of the top 1,000 websites in the US between April 9th and August 27th, 2020. We fitted a conditional latent growth curve model on the data to examine the longitudinal trajectory of the third-party data sharing over the 21 weeks period of the study and examine how website characteristics affect this trajectory. We denote websites that asked for permission before placing cookies on users’ browsers as "privacy-respecting". Results As the weekly number of COVID-19 deaths increased by 1,000, the average number of third parties increased by 0.26 [95%CI, 0.15 to 0.37] P<.001 units in the next week. This effect was more pronounced for websites with higher traffic as they increased their third parties by an additional 0.41 [95% CI, 0.18 to 0.64]; P<.001 units per week. However, privacy respecting websites that experienced a surge in traffic reduced their third parties by 1.01 [95% CI, -2.01 to 0]; P = 0.05 units per week in response to every 1,000 COVID-19 deaths in the preceding week. Discussion While in general websites shared their users’ data with more third parties as COVID-19 progressed in the US, websites’ expected traffic and respect for users’ privacy significantly affect such trajectory. Conclusions Attention should also be paid to the impact of the pandemic on elevating online privacy threats, and the variation in third-party tracking among different types of websites. Lay Summary As the COVID-19 pandemic progressed in the country, the demand for online services surged. As the level of Internet use increased, websites’ opportunity to track and monetize users’ data increased with it. In this research, we examine the extent to which websites increased the number of third-parties with which they share their user’ data and how such practices were moderated by a website’s level of respect for users’ privacy and traffic surge. We find that while the number of third parties increased over time, the websites with higher respect for privacy tend to decrease the number of their parties only if they also experience a significant increase in their traffic.

The Scope and Challenges of Vesicular Carrier-Mediated Delivery of Docetaxel for the Management of Cancer

2020 ◽  
Vol 17 (10) ◽  
pp. 874-884
Author(s):  
Charu Misra ◽  
Kaisar Raza ◽  
Amit Kumar Goyal
Keyword(s):  
The United States ◽  
Drug Products ◽  
Cancer Management ◽  
Vesicular Carriers ◽  
The Us ◽  
United States Food ◽  
Potential Benefits ◽  
States Food ◽  
Us Fda ◽  
Novel Drug

Since the discovery of liposomes, these vesicular carriers have attracted the researchers from all the vistas of the biomedical domain to explore and harness the potential benefits. Many novel drug delivery-based products have been approved by the United States Food and Drug Administration (USFDA) and other federal agencies of the globe, out of which the major share is of the liposomes and related carriers. Taking cognizance of it, the US-FDA has recently come up with ‘Guidance for Industry on Liposome Drug Products’. In cancer management, chemotherapy is the most frequently employed approach which is still not devoid of untoward challenges and side effects. In chemotherapy, the taxanes, esp. Docetaxel shares a huge percentage in the prescription pattern. Also, the first marketed liposomal product was encasing one drug of this category. Henceforth, the present review will highlight the advances in the delivery of taxanes, in particular docetaxel, with an emphasis on the need, success and pharmacoeconomic aspects of such vesicular-carrier mediated docetaxel delivery.

scholarly journals Data Integrity Violations: A Challenge to the Pharmaceutical Industry

2020 ◽  
Vol 11 (01) ◽  
pp. 196-198
Author(s):  
Himani Jaiswal ◽  
Muddukrishna B. S. ◽  
Girish Pai Kulyadi
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Data Integrity ◽  
Regulatory Compliance ◽  
China And India ◽  
The Us ◽  
Standard Operating ◽  
Data Lifecycle ◽  
Us Fda ◽  
The Impact

Data integrity refers to data reliability throughout the data lifecycle. Terminology “ALCOA” means that the data should be attributable, legible, contemporaneously recorded, original, and accurate. “ALCOA Plus” was introduced later. Violation of the integrity of data is termed as a breach of data integrity. It can take place in various fields, but not limited to manufacturing, quality control (QC), quality assurance (QA), and research. Some of the reasons for breach in data integrity are fabrication or duplication of data, out of specification, out of trend, back-dating, manipulation of data, inadequate standard operating procedures (SOPs), common usernames, and shared passwords. A study to assess the impact of data integrity violations based on the US FDA warning letters was conducted. The majority of data integrity breaches belonged to QC. The frequency of letters based on the country has been presented in the form of a graph. China and India received the highest number of letters for breach of data integrity in the year 2018 and 2017 respectively. It can be concluded that it is important to enforce data integrity and develop strategies for the same. The study is beneficial to understand the reason, affected field of work and remediation methods for data integrity, and improve regulatory compliance.

scholarly journals Analysis of Non-Pivotal Bioequivalence Studies Submitted in Abbreviated New Drug Submissions for Delayed-Release Drug Products

2017 ◽  
Vol 20 ◽  
pp. 252
Author(s):  
Paramjeet Kaur ◽  
Xiaojian Jiang ◽  
Ethan Stier
Keyword(s):  
Coating Layer ◽  
Drug Product ◽  
Enteric Coating ◽  
Drug Products ◽  
New Drug ◽  
Delayed Release ◽  
The Us ◽  
Generic Products ◽  
The Impact

The US FDA’s rule on “Requirements for Submission of Bioequivalence Data” requiring submission of all bioequivalence (BE) studies conducted on the same formulation of the drug product submitted for approval was published in Federal Register in January 2009. With the publication of this rule, we evaluated the impact of data from non-pivotal BE studies in assessing BE and identified the reasons for failed in vivo BE studies for generic oral delayed-release (DR) drug products only. We searched the Agency databases from January 2009 toDecember 2016 to identify Abbreviated New Drug Applications (ANDAs) submitted for DR drug products containing non-pivotal BE studies. Out of 202 ANDAs, 43 ANDAs contained 102 non-pivotal BE studies. Forty-nine non-pivotal BE studies were conducted on the to-be-marketed (TBM) formulation and 53 were conducted on formulations different from the TBM formulation. These experimental formulations primarily differed in the ratio of components of the enteric coating layer and/or amount (i.e., %w/w) of enteric coating layer. Of the 49 non-pivotal BE studies conducted on the TBM formulation, 41 failed to meet the BE acceptance criteria. The majority of failed non-pivotal BE studies on the TBM DR generic products had insufficient power, which was expected as these studies are exploratory in nature and not designed to have adequate power to pass the BE statistical criteria. In addition, among the failed non-pivotal BE studies on the TBM DR generic products, the most commonly failing pharmacokinetic parameter was Cmax. The data from these non-pivotal BE studies indicate that inadequate BE study design can lead to failure of the BE on the same formulation. Also, the non-pivotal BE studies on formulations different from the TBM formulation help us link the formulation design to the product performance in vivo. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

scholarly journals Insight on PMDA Regulatory Procedures, Key Stages, Timing, and CMC Requirements for Bio-Therapeutic Products in Japan

2021 ◽  
pp. 1-13
Author(s):  
SEEMA SINGH ◽  
Keyword(s):  
The United States ◽  
Drug Products ◽  
Regulatory Systems ◽  
The Us ◽  
United States Food ◽  
States Food ◽  
Human Use ◽  
Us Fda ◽  
Data Requirements ◽  
Device Agency

The purpose of this manuscript is to provide a basic understanding of legal regulatory systems, marketing authorization application, the Pharmaceutical and Medical Device Agency (PMDA) review process, key stages and timing and CMC (Chemistry, Manufacturing and Controls) requirements in Japan, with a focus on biotherapeutic/biological drug products for human use. The PMDA has some stringent CMC data requirements, which make Japan unique. Japan’s regulatory environment is significantly more complicated than any other country. The level of accuracy and details required by the Japanese regulatory authority is sometimes even greater than the US FDA (the United States Food and Drug Administration), the EMA (the European Medicine Agency) or any other pharmaceutical regulatory agency

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