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

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 Differentiation between the Regulatory paths placed on Mouthwashes in the US and EU

2018 ◽  
Vol 6 (2) ◽  
pp. 8-13
Author(s):  
Philip Saddik ◽  
John Pappan
Keyword(s):  
United States ◽  
The United States ◽  
The European Union ◽  
Oral Diseases ◽  
External Appearance ◽  
Regulatory Systems ◽  
The Us ◽  
United States Food ◽  
States Food ◽  
Therapeutic Properties

Regulating oral rinses has been and still is a topic of debate and confusion. Oral rinses are products that are mainly used for cleaning, perfuming and changing the appearance of the teeth, which in turn improves the individual’s external appearance. Adding medicinal ingredients to these rinses, it can then be used for the elimination and/or prevention of some oral diseases, an example being gingivitis. The United States Food and Drug Administration placed guidelines which state that mouthwashes with possible therapeutic properties should be registered as drugs rather than cosmetics. Meanwhile, on a different continent, Germany along with the other members of the European Union decided not to categorize mouthwashes as drugs, but rather as cosmetics, using its sole purpose of cleaning and beautifying the teeth as the excuse. The following research will thoroughly differentiate between the diverse regulatory systems forced upon mouthwashes across the two countries—the United States and Germany.

An audit of Black Box Warnings (BBWs) in the United States Food and Drug Administration (US-FDA) database - a five-year analysis

2021 ◽  
Vol 16 ◽  
Author(s):  
Debdipta Bose ◽  
Nithya Gogtay ◽  
Tejusv Goel ◽  
Mahanjit Konwar
Keyword(s):  
The United States ◽  
Black Box ◽  
Primary Objective ◽  
Molecular Entity ◽  
Therapeutic Class ◽  
The Us ◽  
United States Food ◽  
Black Box Warnings ◽  
States Food ◽  
Us Fda

Background: The black-box warning (BBW) is the most serious warning that US-FDA can ask for on a drug’s labelling. BBWs represent key safety concerns uncovered either during dossier review or post-approval. We have conducted the present study with the primary objective of assessing BBWs issued by the US-FDA. Methods: BBW’s were identified on US-FDA’s website from 1st January 2015 to 31st December 2019. Prescribing information was used to identify and characterize BBWs into new and minor/major update on a previous BBW. The therapeutic class of the drug, nature [Biological/New Molecular entity (NME)], formulation type, expected duration of use along with the year of first approval of the molecule with BBWs were evaluated. Results: A total of n = 167 BBWs were issued by FDA of which 53 (31.7%) had major updates, 57(34.1%) had minor updates and 57(34.1%) were new BBWs. A total of 137(82%) of BBWs were with NME’s whereas 30(18%) were with biologics. Drugs for neurology 40(25.5%)had the highest number of BBWs followed by oncology 38(24.2%). Among type of BBWs, cardiovascular risk 31 (15%) were the highest. Conclusion: Practicing physicians need to understand that benefit-risk of a drug is dynamic and keep abreast of new data related to it.

scholarly journals Ravulizumab: a novel C5 inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria

2019 ◽  
Vol 10 ◽  
pp. 204062071987472 ◽  
Author(s):  
Robert M. Stern ◽  
Nathan T. Connell
Keyword(s):  
Paroxysmal Nocturnal Hemoglobinuria ◽  
Bone Marrow Failure ◽  
Phase Iii ◽  
The European Union ◽  
Regulatory Review ◽  
Dosing Schedule ◽  
The Us ◽  
United States Food ◽  
States Food ◽  
Us Fda

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare stem cell disorder characterized by hemolytic anemia, bone marrow failure, and thrombosis. Until recently, the complement inhibitor, eculizumab, was the only United States Food and Drug Administration (US FDA)-approved therapy for the treatment of PNH. Although effective, eculizumab requires a frequent dosing schedule that can be burdensome for some patients and increases the risk of breakthrough intravascular hemolysis. Ravulizumab, an eculizumab-like monoclonal antibody engineered to have a longer half-life, is intended to provide the same benefits as eculizumab but with a more convenient and effective dosing schedule. In two recently published phase III non-inferiority trials, ravulizumab was found to be non-inferior to eculizumab both in efficacy and safety for the treatment of patients with PNH. Based on these results, ravulizumab was approved by the US FDA on 21 December 2018 and is currently under regulatory review in both the European Union and Japan.

scholarly journals Analysis of Crowdsourced Metformin Tablets from Individuals Reveals Widespread Contamination with N-Nitrosodimethylamine (NDMA) in the United States

2020 ◽  
Author(s):  
Qian Wu ◽  
Evgenia Kvitko ◽  
Amber Jessop ◽  
Shannon Williams ◽  
Ryan C. Costantino ◽  
...  
Keyword(s):  
United States ◽  
High Resolution Mass Spectrometry ◽  
Daily Intake ◽  
The United States ◽  
Product Recalls ◽  
Acceptable Daily Intake ◽  
Drug Products ◽  
Post Market ◽  
United States Food ◽  
States Food

AbstractRecent reports of metformin drug products contaminated with unacceptable levels of the probable human carcinogen N-Nitrosodimethylamine (NDMA) prompted a national sampling of post-market metformin drug products. To most broadly sample the market and minimize supply chain bias, metformin medication samples were crowdsourced directly from individuals across many states in the United States. 128 samples were received, and liquid chromatography-high resolution mass spectrometry tests for a panel of nitrosamines revealed significant levels of NDMA that trend with labeling company. 42% of all medication samples contained detectable levels of NDMA and, when scaled to maximum daily tablet dose, 36% of all medication samples contained NDMA levels exceeding the FDA daily acceptable intake limit. The highest NDMA detection from the tested samples was 1565 ng per tablet, which, when commonly taken four times a day, is 65 times the United States Food and Drug Administration (FDA) acceptable daily intake limit. Results underscore the need for immediate product recalls of tainted medications and an overall investigation of metformin manufacturing practices.

Abbreviated New Drug Application Process: A Gift for The Industry and The Patients

2021 ◽  
pp. 331-335
Author(s):  
Hindustan Abdul Ahad ◽  
Haranath Chinthaginjala ◽  
Gangireddy Jayasimha Reddy ◽  
Pasupuleti Dheeraj Krishna ◽  
Syed Rahamathulla ◽  
...  
Keyword(s):  
Drug Application ◽  
The United States ◽  
New Drugs ◽  
Brand Name ◽  
Application Process ◽  
Drug Products ◽  
Federal Food ◽  
United States Food ◽  
States Food ◽  
New Drug Application

The United States Food and Drug Administration (USFDA) is one of the main regulated agencies wherein the submission and approval of the new drugs is done. This review is based on the process of submission to the ANDA as per FDA norms as described in paragraph IV submission in Federal Food, Drug, and Cosmetic Act (FD and C Act). No drug would exist in the market until it gets accepted by regulatory authorities. The ANDA submission is for those firms seeking to copy branded drugs before running out of patents to get profit on them. A generic applicant must provide in its application a "certification" that a patent submitted to FDA by the brand-name drug's sponsor and scheduled in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). A Generic Product must meet the standards recognized by FDA in Reference listed drugs (RLD). This study concludes the process of ANDA submission to FDA and acts correlated to the submission in paragraph IV, the details of ANDA filling in the eCTD format and overview of the review process the checklist to the applicant.

Implementation of Question-based Review in support of Quality by Design streamlining the US FDA’s review process

2018 ◽  
Vol 14 (3) ◽  
pp. 129-134
Author(s):  
Alisha Desai ◽  
Jayanta Kumar Maji ◽  
Kanhoba Walavalkar ◽  
Priti J Mehta
Keyword(s):  
Quality By Design ◽  
Review Process ◽  
Critical Material ◽  
Technical Requirements ◽  
The Us ◽  
Product Profile ◽  
United States Food ◽  
Critical Material Attributes ◽  
States Food ◽  
Us Fda

Question-based Review (QbR) is a format proposed by United States Food and Drug Administration (US FDA) enhancing the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use's Common Technical Document (ICH CTD) format to streamline the submission process. It is a question–answer format applied to Quality Overall Summary section of the submission. The format includes putting up questions under every section, so the applicant can submit precise and accurate data for approval of the respective application. The QbR format can be applied to NDA, ANDA, and Type II DMF applications. The companion document available with Manual of Policy and Procedures 5015.10 (MaPP 5015.10) allows the reviewer to inspect the critical information in the data provided. It encourages applicants to encompass Quality by Design (QbD) in their development process. QbR gives a structure through which the data collected by applying QbD can be presented. For effective application of QbR format, the submission should be backed with thorough scientific knowledge, risk assessment data, and data integrity. The questions asked compel the applicant to provide justification for the various decisions made in the development phase. Also, questions regarding quality target product profile, critical quality attributes, critical material attributes, critical process parameters and design of experiment are covered under the QbR format. MaPP 5015.10 finalized by US FDA in 2014 clarifies the concept of QbR. There is MicroQbR available which includes questions confirming the sterility of the product. QbR is a step towards speeding up the review process with an intention to motivate the applicants to implement QbD to the project.

scholarly journals A Broadly Accessible Liquid Chromatography Method for Quantification of Six Nitrosamine Compounds and N,N-Dimethylformamide in Metformin Drug Products Using High Resolution Mass Spectrometry

2020 ◽  
Author(s):  
Qian Wu ◽  
Evgenia Kvitko ◽  
Nicola Zenzola ◽  
Kaury Kucera ◽  
David Light
Keyword(s):  
High Resolution Mass Spectrometry ◽  
The United States ◽  
High Mass ◽  
Chromatography Method ◽  
Drug Products ◽  
Regulatory Guidance ◽  
High Mass Resolution ◽  
United States Food ◽  
States Food ◽  
Liquid Chromatography Method

N-nitrosodimethylamine (NDMA) and the industrial solvent, N,N-dimethylformamide (DMF), are both probable human carcinogens that have been detected in pharmaceutical drug products like metformin, which is used to treat type II diabetes. Some lots of metformin drug products have exceeded the United States Food and Drug Administration (FDA) daily allowable intake limit for NDMA, while the presence of DMF has been detected at several orders of magnitude higher than NDMA. A recent study found that a low abundance isotope of DMF interferes with NDMA quantification by using a unique subset of LC-MS instruments capable of high mass resolution. In this study, an LC-HRMS method is developed that chromatographically separates NDMA from DMF in metformin drug products to eliminate interference. The method can detect nitrosamines and DMF under the current regulatory guidance for industry and provides a solution for simultaneously quantifying nitrosamines and DMF for a broad range of LC-MS instruments.

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