scholarly journals CONVALESCENT PLASMA THERAPY FOR COVID-19 PATIENTS: REGULATORY GUIDANCE ON COLLECTION, TESTING, PROCESSING, STORAGE, DISTRIBUTION, AND CLINICAL TRIALS

2021 ◽  
pp. 6-14
Author(s):  
AMIT PORWAL ◽  
KAMLA PATHAK ◽  
DEVENDER PATHAK ◽  
RAMAKANT YADAV
Keyword(s):  
Clinical Trials ◽  
Systematic Approach ◽  
Drug Application ◽  
Plasma Therapy ◽  
Regulatory Guidance ◽  
Life Threatening ◽  
New Drug Application ◽  
Investigational New Drug Application ◽  
Storage Distribution ◽  
Experimental Stage

Convalescent plasma can be transfused to patients suffering from the same infection or for preparing immunoglobulin concentrates. Plasma obtained from recovered patients can be a valuable alternative during the COVID-19 pandemic for supporting its treatment within a randomized or case-control clinical trials or observational studies of plasma transfusion and for preparing plasma-derived biological products. WHO Blood Regulators Network highlighted that a systematic approach for collecting convalescent plasma from patients recovered from COVID-19 could provide a useful intervention. Structured clinical trials can be used to assess safety and effectiveness of convalescent plasma. The convalescent plasma therapy is still in the experimental stage and is currently not included in the interim clinical guidelines of WHO. However, an emergency investigational new drug application (eIND) process has been induced to ensure the availability of COVID-19 convalescent plasma to the patients with severe or life-threatening COVID-19 conditions. USFDA is regularly amending its guidance as new results, and best practices are emerging. The write-up provides an overview of convalescent plasma, from a regulatory considerations viewpoint, systematic workflow protocol, and a cross-section of clinical trials underway.

scholarly journals Assessing Animal Models of Bacterial Pneumonia Used in Investigational New Drug Applications for the Treatment of Bacterial Pneumonia

2020 ◽  
Vol 64 (5) ◽  
Author(s):  
Ursula Waack ◽  
Edward A. Weinstein ◽  
John J. Farley
Keyword(s):  
Animal Models ◽  
Bacterial Pneumonia ◽  
Drug Application ◽  
Design Elements ◽  
New Drug ◽  
Regulatory Submissions ◽  
Human Use ◽  
New Drug Application ◽  
Investigational New Drug Application

ABSTRACT Animal models of bacterial infection have been widely used to explore the in vivo activity of antibacterial drugs. These data are often submitted to the U.S. Food and Drug Administration to support human use in an investigational new drug application (IND). To better understand the range and scientific use of animal models in regulatory submissions, a database was created surveying recent pneumonia models submitted as part of IND application packages. The IND studies were compared to animal models of bacterial pneumonia published in the scientific literature over the same period of time. In this review, we analyze the key experimental design elements, such as animal species, immune status, pathogens selected, and route of administration, and study endpoints.

scholarly journals REVIEW ON SPONSOR / APPLICANT MEETINGS WITH FDA: HIGHLIGHTS OF NEW GUIDANCE OVER EXISTING

2018 ◽  
Vol 4 (2) ◽  
pp. 19-26
Author(s):  
Charmy Kothari ◽  
Kavina Shah
Keyword(s):  
Clinical Trials ◽  
Management Practices ◽  
Drug Application ◽  
Development Program ◽  
The United States ◽  
United States Department ◽  
Biological Products ◽  
New Drug ◽  
License Application ◽  
New Drug Application

The United States Department of Health and Human Services has a federal agency called the Food and Drug Administration (FDA or USFDA). A pre-planned assembling of two or more people who have been together for the purpose of getting a common goal via verbal interaction is called a formal meeting. During development stage of any drug or biological products pharmaceutical companies face trouble for both scientific and regulatory point of view, here role of formal meetings comes. Formal meetings between sponsor or applicant and FDA are usually related to development and review of drug and biological products. Center for Drug evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regulates the formal meetings. These meetings are applicable to Pre – Investigational New Drug Application, Pre – Biologics License Application, New Drug Application for drugs and biological products and not applicable to Abbreviated New Drug Applications (ANDA), application of medical devices and submission of biosimilar biological products. Meetings between FDA and sponsor or applicant are for resolution of dispute, clinical holds discussion, Assessment of protocols of clinical trial, during clinical trials, in between clinical trials – at the phase 1 ending or at the phase 2 ending, to discuss development program. The FDA has classified these formal meetings in different types based on the nature of the request, the information in the meeting request and each meeting type is handled through different procedures. The principles of Good Meeting Management Practices (GMMPs) must be maintained. There are specific requirements and procedures to request, prepare, schedule, conduct and document formal meetings. As the guidance documents for meetings are revised by FDA, Change in procedure and requirements takes place. Any pharmaceutical company need to be in line with new guidance requirements to avoid rejection. Formal meetings between sponsor or applicant and FDA save time, cost and will increase the probability of product approval.

scholarly journals Age disparity between a cancer population and participants in clinical trials submitted as a new drug application of anticancer drugs in Japan

Cancer ◽  
2007 ◽  
Vol 109 (12) ◽  
pp. 2541-2546 ◽  
Author(s):  
Akiko Hori ◽  
Taro Shibata ◽  
Masahiro Kami ◽  
Eiji Kusumi ◽  
Hiroto Narimatsu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Anticancer Drugs ◽  
Drug Application ◽  
New Drug ◽  
New Drug Application ◽  
Age Disparity
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