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Our Blog
Our Blog
Read the latest news and insights about the Quality Industry.
Read the latest news and insights about the Quality Industry.
The Importance of Clinical Trials
October 4, 2017
Clinical trials are important to test the safety of and effectiveness of drugs. It is a vital step to discover new drugs and treatments for diseases. With clinical trials, researchers can evaluate if the side effects of the new drugs is acceptable compared to the benefits that patients can get.
This often begins in laboratories where scientists develop and test the new treatment or medicine. It often starts with a small group of patients to find out if the new treatment may cause harm or if it will help improve their condition.
There are several types of Clinical Trials:
•Treatment Trials – wherein researchers study drugs (e.g., antibiotics, pain medicines); treatments (e.g., steroid injections, chemotherapy); new approaches to surgery(e.g., dural sealants); novel methods (e.g., gene therapy)
•Prevention Trials – here they study medicines, minerals, vitamins or exercises that may lower the risk of developing certain diseases
•Screening Trials – here they test the best way to find a condition or disease through various methods like MRI or blood tests.
•Quality of Life Trials – Here is the part where they study the benefit of treatments (e.g., side-effect reducing drugs) or lifestyle changes (e.g., support groups)
It is the Food and Drug Administration (FDA) that regulates the use and testing of drugs. FDA requires all new drugs and treatments to pass clinical trials before being introduced to the public.
Clinical Trials help improve and advance medical treatments, they help develop new drugs and treatments for the future.
New Treatment for Adults With Relapsed Follicular Lymphoma Approved by FDA
September 19, 2017
US Food and Drug Administration granted a new treatment for adults with relapsed follicular lymphoma who have already received at least two prior systematic therapies. This new treatment is called Aliqopa (copansilib).
Follicular lymphoma is a type of non-Hodgkin lymphoma.This is a type of cancer that grows slowly. According to the National Cancer Institute at the National Institutes of Health, there are approximately 72,240 people in the United States that will be diagnosed with some form of non-Hodgkin lymphoma this year and approximately 20,140 patients with non-Hodgkin lymphoma will die because of the disease in 2017.
Aliqopa is a kinase inhibitor. It works by blocking enzymes that promote cell growth. Aliqopa received an Accelerated Approval from FDA. The sponsor is currently conducting further clinical trials to confirm Aliqopa's clinical benefit.
Common side effects of Aliqopa include high blood sugar levels (hyperglycemia), decreased strength and energy, diarrhea, high blood pressure (hypertension), nausea, low levels of certain white blood cells (leukopenia, neutropenia), lower respiratory tract infections, and low levels of blood platelets (thrombocytopenia).
Serious side effects include infections, hyperglycemia, hypertension, inflammation of the lung tissue (non-infectious pneumonitis), neutropenia, and severe skin reactions. Pregnant and breastfeeding women should not take Aliqopa to avoid harm to the fetus or newborn baby.
Aliqopa was granted Priority Review designation. The agency will determine that the drug if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
It also received Orphan Drug designation, which provides incentives to encourage the development of drugs for rare diseases.
Bayer Healthcare Pharmaceuticals, Inc. received the approval of Aliqopa from FDA.
Source: http://www.fda.gov
FDA Approves a New Treatment for Acute Myeloid Leukemia​
September 6, 2017
A new treatment for acute myeloid leukemia, has been approved by FDA. The drug called Mylotarg (gemtuzumab ozogamicin) will be used for the treatment of adults with newly diagnosed acute myeloid leukemia with CD33 (CD33-positive AML) tumor. FDA also approved the use of drugs for the treatment of patients 2 years and older with CD33-positive AML who have experienced relapse or who have not responded to initial treatment (refractory).
On May 2000, Mylotarg was initially accelerated as a stand-alone treatment by FDA to treat older patients with CD33-positive AML who had experienced relapse. It was then withdrawn from the market after trials failed to verify clinical benefit and demonstrated safety concerns including early deaths. The approval of Mylotarg today includes lower recommended dose, different schedule in combination with chemotherapy and patient population.
Mylotarg consists of an antibody connected to an anti-tumor agent that is toxic to cells. It works by taking the anti-tumor agent to the AML cells that express the CD33 antigen, blocking the growth of cancerous cells and causing cell death.
Side effects of Mylotarg include fever, nausea, vomiting, infection, low platelet count, swelling and sores in the mouth, constipation, rash, headache, elevated liver function tests and low level of certain white blood cells. Severe side effects include low blood counts, infection liver damage, blockage of the veins in the liver, infusion-related reactions and severe bleeding. It is not advisable for pregnant and breast-feeding women to take Mylotarg due to harmful effects that may affect the baby.
Mylotarg was designated as Orphan Drug which provides incentives to assist and encourage the development of drugs for rare diseases.
The approval of Mylotarg was granted by FDA to Pfizer Inc.
Source: http://www.fda.gov
​New Antibacterial Drugs for cUTI
August 30, 2017
FDA approved a new drug today which cures cUTI (complicated urinary tract infection) and pyelonephritis, a type of kidney infection caused by specific bacteria.
This new drug is called Vabomere. Vabomere was tested in a clinical trial with 545 adults with cUTI, including those with pyelonephritis. After the intravenous treatment, 98% of patient treated with Vabomere had improved/cured symptoms and got a negative urine culture test compared with piperacillin/tazobactam with approximately 94%. Approximately after 7 days of treatment, around 77% of patients treated with Vabomere had resolved symptoms and negative urine culture, while the treatment of piperacillin/tazobactam cured 73% of patients.
According to the research, the most common adverse reaction of patients treated with Vabomere were headache, infusion site reaction and diarrhea. It was also associated with serious risks like seizures and allergic reaction and should not be used in patients with a history of anaphylaxis, a type of severe allergic reaction to products a beta-lactams class of drugs. Also, in order to reduce the development of drug resistant bacteria, Vabomere should only be used to treat patients that are proven or strongly suspected to be infected by susceptible bacteria.
Vabomere was designated as qualified infectious disease product (QIDP), a designation given to antibacterial products that treat serious or life threatening infections and received a priority review.
FDA granted the approval of Vabomere to Rempex Pharmaceuticals.
Source: http://www.fda.gov
Possible Contamination in Multiple Drug and Dietary Supplement Brands According to FDA
August 17, 2017
On August 8, 2017, FDA released a warning on healthcare professionals and consumers not to use liquid drugs and dietary supplements manufactured by Pharmatech LLC of Davie, Florida and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands. According to FDA, this is because of a possible contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection.
Pharmatech LLC manufactures liquid docusate sodium drugs (stool softeners) and dietary supplements including Vitamin D drops and Multivitamins for infants and kids.
“B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems. These products were distributed nationwide to retailers, health care facilities, pharmacies and sold online – making it important that parents, patients and health care providers be made aware of the potential risk and immediately stop using these products,” said FDA Commissioner Scott Gottlieb, M.D.
Consumers, pharmacies and healthcare facilities are advised to immediately stop using and dispensing liquid drugs and dietary supplements manufactured by Pharmatech.
Listed below are distributors who voluntarily recalled the products immediately:
LEADER BRAND
Liquid Multivitamin Supplement for Infants and Toddlers 50 mL, UPC: 096295128611 ALL LOTS
Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL, UPC: 096295128628 ALL LOTS
MAJOR PHARMACEUTICALS
Certa-Vite Liquid 236ML 00904-5023-09 ALL LOTS
Poly-Vita Drops 50ML 00904-5099-50 ALL LOTS
Poly-Vita Drops W/Iron 50ML 00904-5100-50 ALL LOTS
Ferrous Drops Iron Supplement 50ML 00904-6060-50 ALL LOTS
D-Vita Drops 50ML 00904-6273-50 ALL LOTS
Tri-Vita Drops 50ML 00904-6274-50 ALL LOTS
Senna Syrup 237ML 00904-6289-09 ALL LOTS
RUGBY LABORATORIES
C Liquid 500mg 118ML 00536-0160-97 ALL LOTS
Diocto Liquid 50mg/5ml 473ML 00536-0590-85 ALL LOTS
Ferrous Sulfate Elixir 473ML 00536-0650-85 ALL LOTS
Fer Iron Liquid 50ML 50ML 00536-0710-80 ALL LOTS
Senexon Liquid 237ML 00536-1000-59 ALL LOTS
Diocto Syrup 60MG/15ML 473ML 00536-1001-85 ALL LOTS
Aller Chlor Syrup 120ML 00536-1025-47 ALL LOTS
Calcionate Syrup 16OZ 00536-2770-85 ALL LOTS
Cerovite Liquid 236ML 00536-2790-59 ALL LOTS
D3 400iu Liquid 50ML 00536-8400-80 ALL LOTS
Poly-Vitamin Liquid 50ML 00536-8450-80 ALL LOTS
Tri-Vitamin Liquid 50ML 00536-8501-80 ALL LOTS
Poly-Vitamin W/Iron Liquid 50ML 00536-8530-80 ALL LOTS
Source: https://fda.gov
China’s FDA to Speed Up Clinical Application Process
August 10, 2017
To hasten clinical trial approval and to lift restrictions on trial sites, China’s FDA is proposing another set of policy changes. This is to allow drugs to get into the clinic faster.
Currently, facilities are required to pass the certification system. It means that a drug company must wait for CFDA’s official approval before they start a clinical trial. In the new proposal, the agency wants a “no response means approval” mechanism. This means that the agency has 60 working days to reject or approve a trial application.This proposal would allow the researchers to start new studies faster. Though the time frame is longer than US FDA’s 30 days response windows, it is still faster than the previously estimated 195 days turn around time, according to Helen Chen, managing director and head of life sciences with LEK’s Consulting’s China branch.
This is a big step to China’s clinical research. Compared with the Center for Drug Evaluation and Research (CDER) in the U.S. and its 5,000-plus reviewers, the Chinese center is quite understaffed with merely 600 drug evaluation specialists.
Source: Angus Liu, FierceBiotech
Quality Production and P.I.E.
August 2, 2017
FDA continues to promote quality drug production throughout the years. This has been an issue with some companies as they try to keep up with regulations and standards. Some companies struggled with quality and manufacturing problems which led others to shut down, deal with product recall and more.
Today, FDA is implementing a more risk-based inspection model that targets a range of factor related to plant operations and produce characteristics. The agency’s Program Alignment initiative aims to better target inspections by FDA’s field force to high-risk situations, working with a specialized pharmaceutical inspectorate to gain added expertise in evaluating targeted sites. FDA officials also are advancing mutual reliance agreements with competent regulatory authorities in Europe and other regions to establish common standards for pharmaceutical inspections and reduce the need for every agency to conduct its own, often redundant, site visits.
As this inspection model being implemented, we’re here to help you throughout the process. PIE Associates is the new global leader in quality assurance and quality management system development. We are your new partner in compliance.
Quality Means Success
July 24, 2017
A successful company makes a good profit. To have a good profit means targeting a large share of customers from the market. And to do this, you need to have something that all customers are looking for, quality. Quality is something that you cannot just produce overnight. Quality is a result hard work, dedication, organized planning and effective implementation.
Having an organized and positive relationship among the company is one of the keys to produce quality service and products. And this is one of the key attributes that PIE Associates has. Aside from their expertise and knowledge in quality management, the consultants also collaborate and work hand in hand to ensure that their clients will meet their target, which means quality product and services.
Quality upon Quality
July 17, 2017
Quality is something that we are looking for in our daily lives. You are looking for quality when you buy fruits and vegetables from the supermarket. You are looking for quality when you are trying on clothes from the department store. You are even looking for quality when you clean your room. Quality is the first thing that customers will look for in your products when they set foot inside your store. It is also the first thing that they will look for when asking for a service. It is the very first thing that a company should ensure upon manufacturing their product and selling out their service.
Quality is also the promise that PIE Associates guarantee, quality upon quality. PIE Associates will provide you quality service that will help your business succeed. They will ensure that your company will provide quality service and products while you focus on other aspects of your business. From Inspection to Risk Management, and even Project Management, they are the partners and the key to the growth of your business!
The Secret to Success
July 11, 2017
A lot of companies usually have their own Quality Assurance team to achieve their company goals specially with compliance, but mostly, they prefer to look for consulting firms to achieve this so that they can focus on other aspects of the business.
PIE Associates is the one of the newest and most promising consulting firms that can help your company as you find your way to success. Having PIE Associates as your new partner in quality will be your new secret to success. With a dedicated team of experienced and knowledgeable consultants, PIE Associates will focus on the quality and safety of your products and services to make sure that your business will achieve your end goal while adhering to international standards and regulations.
PIE Associates Consulting is Your New Partner in Quality!
June 21, 2017
PIE Associates is a newly established Quality Assurance Consulting firm with wide experienced and expert consultants. PIE employ consultants who think a bit differently. The consultants bring lateral ideas, structured thinking, and clear communication. This company promises to deliver results in a timely manner. PIE provides consultation services on Project Management tools and best practices for business owners & service professionals. Providing comprehensive Project Management Resources information to the aspiring and existing project managers, as well as practical advice on project management processes, templates and tools based on best practices. From GCP (Good Clinical Practice), GLP (Good Laboratory Practice, GLCP (Good Laboratory Clinical Practice) and even Clinical Project Management, PIE Associates can handle it all!
PIE Associates was founded this June, 2017 by Ms. Trudy Hanna, the Managing Director of the Company and Mr. Samuel J Hanna, the Assistant Managing Director. Though the company is new, we cannot deny the fact that Trudy and Samuel are the experts. With 20+ years of experience working as Quality Assurance and Project Lead, Trudy earned the respect and trust of her clients. She is a Certified Quality Auditor (CQA) by American Society of Quality (ASQ); Certified Clinical Research Professional (CCRP) by Society of Clinical Research Associates (SOCra); and is also a Lean Six Sigma Sponsor. Samuel, is also an experienced Microbiologist, with his 10+ years of experience in the field, he definitely has the knowledge and is willing to share it with other companies as well. Together with a team of experts consultants, they promise not only to provide service to other companies, but to be their business partner, providing them solutions to their quality concerns!