The U.S. Food and Drug Administration has issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.
February 19, 2015
David R. Butcher, Marketing Communications, MasterControl
An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Those lacking a solid quality infrastructure are simply not equipped to face the challenges of the regulatory environment and meet the demands of a competitive market.
February 18, 2015
Suzanne M. O'Shea, Counsel, Faegre Baker Daniels LLP
Two years ago, in January 2013, FDA published the final regulations on Good Manufacturing Practices for Combination Products. These regulations are built on the concept that the constituent parts of a combination product retain their regulatory identity as a drug, device, or biological product, even after they are physically, chemically, or otherwise combined into a single-entity combination product (i.e., prefilled injector or drug eluting stent) or co-packaged together. Therefore, all the good manufacturing requirements associated with each constituent part must be complied with in the manufacture of single-entity and co-packaged combination products.
February 10, 2015
Ken Christie COO, VTS Consultants, Inc.
If there is one word within the life science industries that causes concern and anguish it is “audit.” As with any evaluation process, the success of getting through a regulatory audit is a combination of preparedness with regards to what to expect, knowing the current regulations that apply to your product and knowing what tends to be the areas of deficiencies in audits performed. All of these items can be researched on the web and the time and effort to review and provide training on them will serve companies well.
February 5, 2015
Cindy Fazzi, Editor, MasterControl Insider
In a regulated environment, CAPA is a requirement for addressing and mitigating deviations and nonconformances. A quick review of FDA warning letters indicates it’s a dreaded four-letter word for many companies cited for violations.
December 23, 2014
Cheryl Wagoner, Principal Consultant/Owner, Wagoner Consulting LLC
As part of FDA’s efforts to harmonize their requirements with those around the world, it has issued a number of guidance documents to help explain the agency’s position, especially in cases where FDA has some variance with a given international standard. The current FDA guidance regarding biological evaluation of medical devices,
December 2, 2014
Suzanne Junod, U.S. Food and Drug Administration
Most medications used to be expensive – much more expensive than they are today. As recently as the early 1980s, most important drugs on the market were brand names under patent protection. Generics were uncommon; the cost of developing and marketing them in competition with the big brands was too high. Without change, the relative ease with which most of us get and use prescription drugs today might have been quite different.
October 14, 2014
Marie E. Dorat, CQA, CAA IPRF, LLC – RA/QA Consulting & International Product Registration EU-FDA Joint Initiative
The U S Food and Drug Administration (FDA) and European Medicines Agency (EMA) Good Clinical Practice (GCP) initiative started a joint inspection program in September 2009. This inspection program targets investigator sites, sponsors, and contract research organizations (CROs) in either the US or the European Union (EU).
April 17, 2014
by Lisa Weeks, Marketing Communications, MasterControl Inc.
The ability to adapt to change is critical to the success of any business. However, for companies that operate in FDA-regulated or ISO-certified environments, adapting to change and more importantly, being able to control it, is critical to maintaining compliance. Of course, it’s not just regulatory agencies that are demanding higher-quality products; today’s more sophisticated consumers expect the medicines, automobiles, and devices they purchase to be safe and effective, too. They also expect them to cost less and be developed more quickly and efficiently. Better, safer, faster, cheaper…it’s a tall order for any regulated company. Organizations that respond quickly to increased regulation and consumer sophistication will become inherent market leaders. How does your company respond to change?
April 3, 2014
by David Lim, President and Principal of Regulatory Doctor and Yoonhee Beatty, Regulatory Affairs Associate, Bard Access Systems, Inc.
We present a summary of available options to request additional review of FDA decisions or actions, including how to choose an option when a stakeholder has reasonable grounds to disagree with FDA/CDRH’s decision. It is worthwhile to note and get familiarized with the available options. However, it is recommended the stakeholder try to avoid having such situations in the first place.
March 26, 2014
by John E. Lincoln, J.E. Lincoln and Associates
Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products. For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others.
October 24, 2013
Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.
In clinical research, there are two major regulatory concerns: patient safety and data integrity. While there are many possible reasons for regulators to conduct an inspection during a clinical trial, most of the time, it’s to verify these two things and to ensure that the research is being conducted according to the study protocol and GCP regulations.
May 3, 2012
Dr. Robbie Wong, Pharm.D., Clinical Development Consultant and Affiliate Assistant Professor, Dept. of BioEngineering, University of Washington
It's not exciting, it's not cutting edge. It may be the last thing you think about when preparing for an FDA audit. You might scan the records and figure if all the lines are filled in, it must be okay. Or, the auditor might not look at it, so I will trust that the pharmacist did it correctly. After all, aren't pharmacists one of the most trusted professions? Consider this: if drug accountability is in question, then the whole study could be in jeopardy. Proving that the drug was administered to the patient that resulted in the effects seen from study drug is a key factor in determining the merit of a product candidate. The FDA has listed drug accountability as number three in a list of top five pitfalls.