Multiple Authors
By: Howard Sklamberg, Jeffrey Shuren, Melinda Plaisier

Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review and analysis of that data, which in turn can promote the practice and culture of quality within firms.

Russ King’s picture

By: Russ King

As medical science has advanced, products submitted for FDA review are using increasingly complex formulations, including unique and creative combinations of drugs, biologics, and devices. Because of this complexity, combination products, by definition, may require intercenter consultations with the FDA.

By: Ken Miller

Has your organization secured all its electronic healthcare records (EHR)? If not, don’t wait to put the proper policies and procedures in place. If you’ve already secured your EHR, then make sure that you’re ready for an audit by the Office for Civil Rights (OCR).

Eston Martz’s picture

By: Eston Martz

I read trade publications that cover everything from banking to biotech, looking for interesting perspectives on data analysis and statistics, especially where they pertain to quality improvement.

Michael Causey’s picture

By: Michael Causey

Just when we’d all decided Washington lawmakers won’t accomplish much beyond enjoying their own excellent health insurance coverage, tasty bean soup in the Senate cafeteria, and the best parking on Capitol Hill, it turns out they might actually unite to accomplish something pretty big after all.

Patrick Stone’s picture

By: Patrick Stone

The FDA says that investigational review boards (IRBs) aren’t required to collect a statement of investigator assurance from studies they preside over.

Michael Causey’s picture

By: Michael Causey

Jon Speer’s picture

By: Jon Speer

When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a lot of emphasis on inputs and outputs, verification, transfer, and the design history file. All good things, of course; without them, you won’t meet FDA requirements for your design controls. The problem, however, is that too often people forget to ask themselves “Why?”

Larry Spears’s picture

By: Larry Spears

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.

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