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Larry Spears

FDA Compliance

Three FDA Initiatives That Affect Life Sciences

How the program alignment, case for quality, and transparency initiatives help healthcare

Published: Tuesday, April 14, 2015 - 10:45

If you’ve been in the life science industry for awhile, you know it never gets easier but instead more complicated year after year. For example, unique device identification (UDI) requirements, combination product rules, and updated electronic medical device reporting (eMDR) requirements add to the complexity of a quality management system for good manufacturing practices (GMP) requirements.

As far as the regulatory environment is concerned, patients are expecting an increase in product quality, so the U.S. Food and Drug Administration (FDA) isn’t letting compliance overshadow quality. The FDA is spearheading a number of initiatives, such as Program Alignment, Case for Quality, and Transparency, to help shed light on the agency’s collaboration with the life sciences industry and the public.

Guidance documents are a key communication tool for the FDA. To keep the industry and public informed about a specific regulation, the FDA issues many guidance documents about how it intends to implement the regulation. While the regulation is being developed, as well as after it’s implemented, the agency tries to address questions or concerns that have come to their attention.

As the FDA moves into new areas of regulation, such as mobile applications and pharmacy compounding, it routinely issues guidances and holds public meetings to talk about the current issues, ask for feedback, and then use that information to decide how much and how far it’s going to regulate. Basically, the agency first figures out what’s happening in the industry and what the user risks are, how much regulation it should apply, and how much investment of resources is needed to provide an appropriate level of public health protection.

Recently, the FDA has released guidance documents about combination products, low-risk devices, medical device accessories, analytical procedures and methods validation for drugs and biologics, and the qualification process for drug development tools, among others.

Program Alignment

A new FDA initiative called Program Alignment began in 2014. This multiyear project will help the agency address new challenges specific to scientific innovation, increased biomedical discoveries, and globalization as it looks at managing those things in conjunction with its mandate as a public health agency. This program helps ensure the agency’s thinking, operations, and resources are better aligned between field offices and headquarters. The intent is to have everyone working together so they will invest their resources collaboratively and effectively across the agency.

Case for Quality

The Case for Quality initiative is a partnership between the FDA and the medical device industry. The FDA is trying to determine how to regulate the industry through various activities such as inspections, and how to improve product quality. The FDA reviewed data from inspections and was concerned that, even with established regulatory requirements in place, many manufacturers still had rates of noncompliance that remained unchanged for years. The FDA needed to figure out what could be done to help improve quality. It found barriers within FDA and industry that inhibited the design and production of high-quality devices. For example, the agency is working with the medical device industry to find ways to improve quality by looking at different ways to perform inspections. Also, the FDA’s Center for Drug evaluation and Research (CDER), has created a new Office of Pharmaceutical Quality to highlight and consolidate quality throughout the drug life cycle.


The Transparency initiative allows the FDA to provide information to the public about product approvals, new initiatives, and regulations violations for most regulated products by posting untitled letters and warning letters on its website. It has also begun publishing 483 inspection summaries, and compliance and recall data.


As with other regulatory enforcement agencies, the FDA faces challenges as it moves forward globally. It must ensure it covers a broader inventory. In life sciences, more products are currently manufactured outside of the United States than inside for U.S. consumption, and this trend is continuing. As more companies establish operations offshore, the FDA must continue to ensure oversight of those products entering the U.S.

Because of this expansion of life science production outside the United States, the FDA has determined that the best way to manage regulatory resources to cover those operations is through collaboration with regulatory authorities throughout the world. For some areas, this includes regular conference calls and meetings with regulatory counterparts. The agency has also established 13 offices in six countries, enhanced screening of imported products, and is relying more on post-market safety signals.

There are many factors that influence the safety and efficacy of products being used by patients in the United States. The FDA’s role is an extremely important one but not at all easy. Its guidance documents and public meetings provide the life science industry with an opportunity to see what’s happening within the agency and to weigh in on important issues. The new programs and initiatives created by the FDA open up dialogue in the industry and provide a forum for the public to share its thoughts and concerns about the future of our healthcare products.

Register for the webinar, “FDA Initiatives and Regulatory Trends for Life Sciences,” presented by Larry Spears in conjunction with Sparta Systems and Quality Digest, on Tues., April 21, 2015, at 11 a.m. Pacific. 


About The Author

Larry Spears’s picture

Larry Spears

Larry Spears, president of L. Spears Consulting LLC, spent 34 years at the U.S. Food and Drug Administration (1977–2011); his last position was Deputy Director for Regulatory Affairs. He also served as Director and Deputy Director of the Division of Enforcement as well as Compliance Officer where he gained extensive knowledge and experience in the application of FDA law, regulations, and policy relating to compliance and enforcement programs and strategy. He most recently was director in enterprise risk services for life sciences at a Big Four consulting firm, where he helped clients develop quality and risk strategies in regulatory governance, contract manufacturing, and validation.