Ryan E. Day’s picture

By: Ryan E. Day

One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years. The FDA has broad jurisdiction to regulate all health products, and it also has the freedom to not exercise that authority (enforcement discretion) as it sees fit. This puts Finch in the delicate position of providing a product that is regulated by the FDA, yet isn’t actually bound by any existing regulatory statutes, such as 21 CFR.

Finch is a clinical-stage microbiome therapeutics company dedicated to developing novel microbial therapies to serve patients with serious unmet medical needs. Built on 30 years of translational research at OpenBiome, MIT, the University of Minnesota, the Center for Digestive Diseases, and Crestovo, Finch uses its unique Human-First Discovery approach to develop therapies from microbes that have demonstrated clinically significant impacts on patient outcomes.

Matthew M. Lowe’s picture

By: Matthew M. Lowe

Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage current industry players to blaze new trails. Whether new or established, life science companies share a common need as a prerequisite to success: regulatory compliance.

A new medical product deemed unsafe or ineffective by regulators will never reach patients, no matter how innovative it is. Noncompliance can make or break a regulated company, especially if the violation leads to serious adverse events or a product recall.

Andreas Engelhardt’s picture

By: Andreas Engelhardt

An international standard that specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018—“Occupational health and safety management systems–requirements” replaces OHSAS 18001 as the primary OH&S standard used internationally. It follows other management system approaches, including ISO 14001 and ISO 9001, and can help organizations develop a framework that improves safety, reduces workplace risks, and creates safer working conditions.

The growing globalization and fragmentation of supply chains has increased the levels of OH&S risk for multinational organizations because their business functions, and those of their suppliers and customers, cross multiple geographic boundaries. Without the assurance of a robust OH&S across that supply chain, an organization may be unwittingly exposed to substantial legal, financial, and reputational damage.

Richard Pazdur’s picture

By: Richard Pazdur

During the past decade, advances in understanding of cancer biology have led to the development of targeted treatments that are more effective than the chemotherapies of the past century. These therapies are demonstrating response rates large in magnitude or response durations prolonged in early trials, or both. Patient demand to enter these trials has increased, and so have calls to expedite the drug development and approval processes, all while maintaining high standards for safety and efficacy.

The U.S. Food and Drug Administration (FDA) never loses sight of its dedication to patients faced with a life-threatening disease, and to making progress in the fight against cancer.

The administration works with industry, researchers, and other stakeholders developing innovative cancer therapies to ensure clear understanding of the FDA’s latest thinking on how clinical trials can be efficiently and effectively designed to demonstrate a cancer therapy’s safety and efficacy.

Last week, the FDA published a draft guidance to help advance effective and innovative clinical trial designs early in drug development to help bring new cancer therapies to patients as quickly as possible. Below is a quick summary of this guidance:

Mike Richman’s picture

By: Mike Richman

‘Culture” is one of those business-speak words that’s used a lot, but for a good reason—having the right one is the key to unlocking your company’s quality potential. On the other hand, nothing will overcome a poor culture. Do you know which you have? We explored these issues during the Aug. 10, 2018, episode of QDL.

“Lockheed Martin Meets 1,800 Employee Hiring Commitment”

Promise made, promise kept! The major aerospace and defense contractor is hiring production staff for its F-35 multipurpose fighter jet program.

“The Truth About Manufacturing”

Jay Timmons, president and CEO of the National Association of Manufacturers (NAM), has been meeting with manufacturing executives and workers to better understand the issues facing industry today.

Multiple Authors
By: Vanessa Burrows, Suzanne Junod, John Swann

During the early 20th century, Americans were inundated with ineffective and dangerous drugs, as well as adulterated and deceptively packaged foods.

A cosmetic eyelash and eyebrow dye called Lash Lure, for example, which promised women that it would help them “radiate personality,” in fact contained a poison that caused ulceration of the corneas and degeneration of the eyeballs. An elixir called Banbar claimed to cure diabetes as an alternative to insulin, but actually provided no real treatment and caused harm to those patients who substituted this for effective insulin therapy.

Food producers short-changed consumers by substituting cheaper ingredients. Some products labeled as peanut butter, for instance, were filled with lard and contained just a trace of peanuts, and some products marketed as “jellies” had no fruit in them at all. Unscrupulous vendors even sold products to farmers, falsely promising they could treat sick animals—in at least one case, a product called Lee’s Gizzard Capsules killed an entire flock of turkeys instead of curing them.

Matthew M. Lowe’s picture

By: Matthew M. Lowe

The medical marijuana industry is being heralded as the new frontier in the life sciences, thanks to the potential of cannabis-derived products in treating ailments that range from chemotherapy-induced nausea to epilepsy and neuropathic pain. If you’re a startup in the industry, what does this mean for you? In a nutshell, it means opportunities abound, but regulatory uncertainty remains.

For the medical marijuana industry to earn public trust, it must find a clear regulatory path. The industry’s journey toward that path resembles what the nutraceutical and tobacco industries faced in the past.

Nutraceuticals and cigarettes are popular among consumers throughout the world, but their manufacturers suffered the stigma of being unregulated for a long time. Without the stamp of regulatory approval, many people considered dietary supplements dubious. Likewise, cigarette companies were deemed unethical.

It wasn’t until 1994 that the U.S. Food and Drug Administration (FDA) began to regulate the nutraceutical industry under the Dietary Supplement Health and Education Act.1 The FDA’s regulation of tobacco products came in 2009, prompted by the Family Smoking Prevention and Tobacco Control Act.2

Janet Woodcock’s picture

By: Janet Woodcock

The staff of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) always tries to utilize cutting-edge science and up-to-date process management, befitting our stature as the global “gold standard” in drug regulation. Maintaining that standard requires us to keep up with evolving technology and the latest scientific, medical, and regulatory advances.

Current factors impacting drug development include the genomic revolution, the rise of targeted therapy, the availability of digital health data, the focus on patient involvement, complex drug-device combinations, globalization of drug development, and harmonization of international standards. To be successful drug regulators, we reach well beyond the borders of the FDA. We collaborate with a wide variety of medical and scientific organizations such as those in biomedical research, the pharmaceutical industry, academia, global organizations, and other regulatory agencies. Importantly, these collaborations also extend to patients and their caregivers and advocacy groups. All these interactions are critical to successful drug regulation.

Malvina Eydelman’s picture

By: Malvina Eydelman

The U.S. Food and Drug Administration’s (FDA) Breakthrough Devices Program is beginning to show important results for patients since it was established in late 2016 under the 21st Century Cures Act to help patients gain timely access to breakthrough technologies.

Consider Second Sight Medical Products Inc.’s Orion Cortical Visual Prosthesis System, which recently qualified for the FDA’s voluntary Breakthrough program.

Eligible technologies must provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. In addition, there must be no approved or cleared treatment, or the device must offer significant advantages over existing approved or cleared alternatives.

AssurX’s picture

By: AssurX

Recent FDA warning letters indicate that many drug manufacturers do not have their manufacturing in a state of current good manufacturing practices (CGMPs) control. During the first half of 2017, the FDA cited adulterated products and insanitary conditions as the two most common violations in drug manufacturing. Here are four ways an automated quality and compliance management system builds control into the production process with respect to adulteration and potential contamination.

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