Accelrys, a provider of scientific innovation lifecycle management solutions, has acquired Ireland-based QUMAS, a global provider of Cloud-based and on-premises enterprise compliance software supporting regulatory and quality operations in life sciences and other highly regulated industries.
Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has extended the...
AcelRx Pharmaceuticals, Inc. has announced that the Zalviso New Drug Application (NDA) was...
This class action seeks to recover damages against the Company and certain of its officers and directors as a result of alleged violations of the federal securities laws.
GW Pharmaceuticals announced today that the U.S. Food and Drug Administration has granted orphan drug designation for Epidiolex, which contains plant-derived Cannabidiol (CBD) as its active ingredient, for use in treating children with Dravet syndrome, a rare and severe form of infantile-onset, genetic, drug-resistant epilepsy syndrome.
Genentech announced today that the U.S. Food and Drug Administration (FDA) approved Gazyva (obinutuzumab), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia.
The FDA asked Ariad to stop marketing the drug, but the company is negotiating with the FDA about changes to prescribing information and new ways to manage the risks associated with Iclusig. Ariad said it wants to resume marketing the drug. The daily pill is Ariad's only approved product.
The late, great Yankees player and coach Billy Martin was not known for holding his tongue. Through many seasons as the Yankees skipper, Martin had more than his fair share of arguments, ejections and fights with umpires and, of course, Yankees owner George Steinbrenner.
It’s only a few weeks in to the New Year and it’s sad to say that 2012 is already shaping up to be as bad as 2011 was in regards to pharmaceutical product recalls.
My definition of “specification” is rather simple: it’s a promise. Just like any other promise—you’d better be sincere when you make it and able to keep it. Failure to keep a promise brings disappointment. Frequent failure leads to distrust. And consciously breaking a promise is nothing less than deceitful.
I remember a class exercise in "Quality School" in which you counted the number of F’s in a paragraph. Remember? The one where you got a different number with each try? The point was to illustrate: one hundred percent inspection does not detect defects one hundred percent of the time.
In response to several high-profile industry incidents that have had significant implications for consumer safety, the FDA is investing greater time and resources in its review and oversight of the pharma industry as a whole.
FDA 483 letters are expected to increase this year, reflecting the FDA’s recent staff expansion and rewrite of the FDA 483 Letter rules to narrow response time to the new 15-day window
For years, life sciences companies have struggled with the documentation burden associated with software validation. Over the past two decades, there has been much discussion about “paperless” validation.
Key tactics to help incorporate reimbursement planning early in development include stage gates, regulatory affairs road-mapping, and clinical regulatory strategic plans
Good communication is a hallmark of trust. If people know they can count on you to communicate well, to articulate thoughts in ways that are understandable to any listener, then people will see you - and the programs you champion - as worth paying attention.
Improvements to quality systems at pharmaceutical and medical device companies can result in lower operating and compliance risk, improved ability to successfully launch new products and higher profitability. The current state of quality systems at many pharmaceutical and medical device companies is one that demands attention.
As part of a highly regulated industry, pharmaceutical companies follow stringent quality control procedures to ensure the final product is free of contaminants and defects. Although rare, contamination does occur during the drug manufacturing process. During a visual inspection, trained quality control inspectors can see product defects as small as 50 µm in size. If at this stage the contaminants can be identified, steps can immediately be taken to eliminate the source of contamination from the manufacturing process.
With so many moving parts, the ability to repeatedly execute clinical trials with a high level of quality requires a comprehensive and adaptable Clinical Quality Management (CQM) program. The starting point of any CQM program consists of well-defined and documented Standard Operating Procedures (SOPs) for every aspect of running a clinical trial, including the peripheral departments and outsourced services/providers that play a vital role in your ability to execute clinical studies.
Delivering Excellence: Innovative equipment applications and a forward-looking design help build an advanced API facilityAugust 26, 2009 9:31 am | Articles | Comments
Orchid Chemicals & Pharmaceuticals Limited's desire to build a cost effective, well-integrated, intermediate and sterile API facility, with state-of-the-art building/technical concepts and equipment has resulted in their Aurangabad carbapenem facility winning the 2009 Facility of the year award for Regional Excellence.
Pharmaceutical manufacturers operate in one of the most highly regulated industries ? facing an array of restrictions and requirements from the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), various state and foreign governments, and their individual customers.
Alphabets are the basic building blocks of any language. Our collective proficiency in them allows us to express ourselves to others. Similarly, in the pharmaceutical manufacturing industry, we have to have complete command of its unique alphabet in order to successfully design and manufacture drugs.
What is "laboratory compliance"? It is a general term used by many people, but which means different things to different people. There is no definitive answer or even one in Wikipedia the "on-line" encyclopedia!
At INTERPHEX, in March 2009, an expert panel convened to discuss the challenges facing the pharmaceutical industry in meeting the FDA's guidance regarding e-pedigree, and to address the larger global issues surrounding the implementation of RFID as part of a secure supply chain solution.
Through the years, there has been very little change in the appearance of components in packaging and delivery systems for injectable drug products. The material science and manufacturing technologies that go into the creation of these systems, on the other hand, have undergone significant advancement.
Since the release of 21 CFR Part 11 in 1997, the validation and verification of electronic records has been at the forefront of the Information Technology (IT), Quality Assurance (QA) and Regulatory departments of the medical device and pharmaceutical industries.
Most are familiar with X-Ray technology and its use in airports to inspect baggage or in medical and dental offices for examinations. However, the general public is less aware of the important role X-Ray technology plays in the pharmaceutical and other industries
Microbiology Innovation: The Evolution of Microbiological Methods Into The 21st Century at Ortho-Clinical Diagnostics (Rochester, NY)March 6, 2009 7:00 am | Articles | Comments
Ortho-Clinical Diagnostics Microbiology Department in Rochester, NY, has demonstrated innovation by using the Process Excellence Define; Measure; Analyze; Innovative/Improvement; Control Road Map (DMAIIC) to improve the product release process. By selecting a rapid technology, testing cycle time was reduced as well as warehouse storage costs.
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