Azadeh Shoaibi’s picture

By: Azadeh Shoaibi

The word “prism” might make you think of a triangular piece of glass that separates white light into a rainbow of colors. But at the U.S. Food and Drug Administration (FDA), it means a powerful, computer-based system that separates critical bits of information from vast streams of healthcare data in order to investigate adverse events and determine if there is a connection to a specific vaccine.

The FDA “prism”–called Post-licensure Rapid Immunization Safety Monitoring System (PRISM)—might not have such a colorful name, but it’s a bright light in the agency’s continual efforts to identify adverse effects in a timely manner.

PRISM is a cooperative effort between the FDA’s Center for Biologics Evaluation and Research and its partners in the healthcare and medical insurance communities. It analyzes health-insurance claims data from four national healthcare plans: Aetna, HealthCore (Wellpoint), Humana, and OptumInsight (United Healthcare).

Since it was first inaugurated in 2010, PRISM has made valuable contributions to public safety.

Multiple Authors
By: Brenda Stodart, Renu Lal

It is well known that small business is vital to the success of the U.S. economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development.

We may think of the pharmaceutical industry in terms of giant corporations, but the fact is that there are hundreds of small firms—with very few employees—that are developing many of the important drugs that we use every day. The U.S. Food and Drug Administration (FDA) defines a small business as one with fewer than 500 employees (including employees of affiliates), but many are much smaller.

Industry sources indicate that, during the past decade or so, more than half of the novel drugs (i.e., those not previously marketed in the United States) developed in this country and approved by the FDA, have been developed by small companies. Small companies also affect the generic drug industry, creating market choice, competition, and increased access. According to FDA data, of the 2,176 new and generic drug applications submitted to the agency in 2014–2015, at least 639, or about 29 percent, were submitted by firms with fewer than 500 employees.

Jon Speer’s picture

By: Jon Speer

If you’re in the medical device industry, you may think that design controls are a confusing imposition on your processes. But they’re a necessary part of your requirements as a medical device developer, and I’ve noticed that this area tends to be rife with misconceptions, confusion, and generally making things into a bigger deal than they really need to be.

That being said, there are some areas that I’d like to address to help medical device engineers navigate their way more easily through design controls requirements. Let’s take a look:

1. Don’t believe the misconceptions

Probably the biggest misconception about design controls is that they equal a heavy load of burdensome documentation. People who believe this also often believe statements like: “Following good design controls will only slow down our product development” and, “Design controls will stifle innovation in our business.”

Multiple Authors
By: Suzanne Junod, John Swann

The U.S. Food and Drug Administration’s (FDA) “History Vault” contains more than 10,000 artifacts that provide a journey through U.S. history and document the critical role played by one of the nation’s oldest public health agencies during its mission to promote and protect American health.

These items, which are featured in a new series of short videos, reflect the constant changes in science and society. It is the responsibility of the FDA’s history office to document and share these changes through the collection, management, and display of these rare, and in many cases, irreplaceable items.

Besides collecting and maintaining these articles, the office embraces the broader role of history: to inform, explain, and educate, so that future decisions are made with the best available knowledge and science.

The collection includes deceptive and dangerous foods, medicines, and so-called medical products that the FDA helped remove from commerce, and that led to important changes in laws and regulations.

AssurX’s picture

By: AssurX

Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.

In December 2016, Director Janet Woodcock laid out some of the broader goals for 2017 around the same time Congress approved the epic 21st Century Cures Act. If all goes according to plan, the FDA will have more funding to do its job—including more inspections of life sciences manufacturers.

The 21st Century Cures Act gives the FDA a bonus of $500 million over 10 years to further fund an initiative to use real-world evidence in regulatory decisions. That makes it all the more important for manufacturers to have a strong document management system in place to be able to organize, access, and have the ability to provide detailed data to the agency if requested.

Jon Speer’s picture

By: Jon Speer

If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not only provides a needed function to a patient, but is also proven to be safe to use—maybe even used by someone who is near and dear to you.

Risk management can be a daunting and often confusing subject. Even the most experienced businesses trip over it from time to time, so it always pays to keep your knowledge up to date.

We looked into some key challenges that have been common in risk management lately, because it’s always good to know where the challenges lay, and what to do about it. Here is what we’ve found:

Multiple Authors
By: Robert M. Califf, Nina L. Hunter

About a year ago, we shared with you our combination product review, Intercenter Consult Process Study Report, developed by the U.S. Food and Drug Administration’s (FDA) Office of Planning. The report findings were derived from focus group studies with reviewers from the FDA’s different centers and included input from industry. Since then, we have built on foundational policies and processes to address many of the issues identified in the report.

Tremendous progress toward modernizing the combination products review program has been made by improving coordination, ensuring consistency, enhancing clarity, and providing transparency within the agency as well as with all stakeholders. We are excited to share our progress with you now. The table below summarizes some key achievements from the past year, including the publication of draft guidances, a variety of new processes, and a look at future goals.

Dara Corrigan’s picture

By: Dara Corrigan

For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this concern would be to create an expanded inspectorate, one where investigators and inspectors from the FDA and trusted partners, such as those in the European Union (EU), would work together, rely on each other’s inspections, avoid duplicating inspections, and conduct more inspections in areas where the increase in drug manufacturing has greatly increased, like in China and India.

To meet this challenge, the FDA has responded with the Mutual Reliance Initiative (MRI). The concept is simple. EU country inspectors inspect in their respective countries, the FDA inspects the manufacturing facilities in the United States, and the EU and the FDA would rely upon each other. This would avoid duplication, lower costs, and enable the regulators to devote more resources to other parts of the world where there is greater risk. The savings would be considerable—over the last five years, about 40 percent of the FDA’s drug inspections were performed in the EU.

Michael Causey’s picture

By: Michael Causey

The Department of Health and Human Services (HHS) hit hospitals and other healthcare delivery networks hard in the pocketbook with a wave of big fines zeroing in on security risk management issues between July and October. Is this the end of the fine tsunami? Don’t bet on it.

In the most recent example, St. Joseph Health (SJH) agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules following reports that files containing electronic protected health information (ePHI) were publicly accessible through internet search engines for more than a year, ending in 2012. SJH, a nonprofit, integrated Catholic healthcare delivery system sponsored by the St. Joseph Health Ministry, will pay a settlement amount of $2.14 million and adopt a comprehensive corrective action plan.

AssurX’s picture

By: AssurX

Life sciences companies around the world should make sure their corrective and preventive action (CAPA) plans are in good shape before a Food and Drug Administration (FDA) inspector comes calling. Looking at a deep pool of letters issued this year domestically and internationally, it’s clear the agency will focus like a laser on CAPA.

The good news is that taking a look at FDA inspection patterns can help medical device manufacturers proactively assess and improve their own programs.

In a June 30, 2016, warning letter, the agency zeroed in on the CAPA program at TriMed, a manufacturer of implantable bone fixation systems based in Santa Clarita, California. Long story short: It didn’t like what it found. Here’s why:

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