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Accelrys Acquires QUMAS

December 10, 2013 8:42 am | News | Comments

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 Receives Notification from FDA of PDUFA Date Extension for ALPROLIX™

December 2, 2013 8:01 am | News | Comments

Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has extended the...

Zalviso New Drug Application Accepted for Filing by FDA

December 2, 2013 7:58 am | News | Comments

AcelRx Pharmaceuticals, Inc. has announced that the Zalviso New Drug Application (NDA) was...

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Class Action Suit Filed Against ARIAD Pharmaceuticals

November 22, 2013 10:29 am | by Associated Press | News | Comments

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.                                       

FDA Grants Orphan Drug Designation To Cannabis-Derived Pediatric Epilepsy Drug

November 15, 2013 9:52 am | by Associated Press | News | Comments

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. 

FDA Approves Gazyva For Lymphocytic Leukemia

November 1, 2013 11:38 am | by Genentech | News | Comments

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.


Ariad Suspends Sales Of Cancer Pill Due To Blood Clots

October 31, 2013 10:19 am | News | Comments

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.

Seeing Both Sides

January 25, 2013 3:13 pm | by Mike Auerbach, Editor In Chief | Blogs | Comments

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.

New Year - New Recall

January 11, 2012 6:34 am | by Mike Auerbach, Editor In Chief | Blogs | Comments

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.

When All Else Fails, Lower Your Standards

October 18, 2010 4:29 am | Blogs | Comments

  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.

We have reviewed your firm's FDA 483 response, however...

October 11, 2010 4:26 am | Blogs | Comments

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.


The Unforeseen Audit – Is Your Company Ready?

March 12, 2010 5:26 am | by Tim Mohn, Industry Principal, Sparta Systems’ Product Management Group | Blogs | Comments

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 Should Trigger Action - Not Panic

March 1, 2010 11:31 am | by Ken Appel, VP Regulated Markets, Veriteq Instruments | Blogs | Comments

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

Green Validation: Practical Strategies For Paperless Software Validation

February 24, 2010 7:27 am | by Valarie King-Bailey, CEO, OnShore Technology Group | Articles | Comments

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.

Reimbursement: Plan Early

February 24, 2010 6:58 am | by John Avellanet, Cerulean Associates LLC | Blogs | Comments

Key tactics to help incorporate reimbursement planning early in development include stage gates, regulatory affairs road-mapping, and clinical regulatory strategic plans

Three Tips to Elevate Your Compliance Communications

February 1, 2010 9:37 am | by John Avellanet, Managing Director & Principal, Cerulean Associates | Blogs | Comments

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.  


The Future of Pharmaceutical Quality Systems: A Need For Action

October 28, 2009 5:35 am | Articles | Comments

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.

Microextraction Explained: Isolating soluble contaminants in pharmaceutical tablets

October 20, 2009 6:02 am | Articles | Comments

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.

Measuring and Monitoring Quality in Global Clinical Trials (11362)

October 14, 2009 5:31 am | Articles | Comments

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 facility

August 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.

Compliance Documents: Solving the Puzzle

July 14, 2009 8:09 am | Articles | Comments

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.

Hesitation In The Drive To A Continuous Pharmaceutical Manufacturing Process: Real or Imaginary?

July 7, 2009 8:20 am | Articles | Comments

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.

Laboratory Compliance: Making The Grade

June 1, 2009 11:13 am | Articles | Comments

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!

Security and RFID's Place in the Pharmaceutical Supply Chain

May 11, 2009 10:13 am | Articles | Comments

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.

Needles And Pins

March 12, 2009 6:53 am | Articles | Comments

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.

Validating Electronic Spreadsheets or Automated Forms

March 9, 2009 11:22 am | Articles | Comments

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.

A Closer Examination of X-Ray Technology…Answers to Your Most Asked Questions

March 6, 2009 7:00 am | Articles | Comments

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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