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Life Sciences Decoded

Life Sciences Decoded

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The FDA's new Digital Health Plan

Diane Romza-Kutz August 22, 2017

Life sciences partner Diane Romza-Kutz describes what's known so far about the FDA's Digital Health Plan in this July article published by Digital Health Legal. READ MORE

FDA’s Health Software PreCert Program to fast-track innovation


The FDA has created the Software Precertification Pilot Program to accelerate and streamline the regulatory approval process for new, disruptive, and innovative products. READ MORE

FSVP compliance dates arrive, challenges to food industry increase

international food

The FDA's Foreign Supplier Verification Programs for human and animal foods have gone into effect. Find out how the FDA will approach preliminary enforcement during the first few months of the new regulations. READ MORE

Privacy and the Internet of Medical Things: What’s a curmudgeon to do?

Diane Romza-Kutz Matt Hafter April 12, 2017

The proliferation of Internet-connected and controlled medical devices opens up bundle of cybersecurity risks and concerns. What stance has the FDA taken so far an where is it headed? READ MORE

FDA sanitary transport rule impacts railroads, other shippers

Diane Romza-Kutz April 4, 2017
railroad food

The Food and Drug Administration’s new Sanitary Transport of Human and Animal Food Rule takes effect on April 6, 2017, imposing new rigorous food safety regulations on food shippers – including railroads. READ MORE

What the FDA has in store for the food industry in 2017

food 2017

Both the human and animal food industries have a great deal of change confronting them under the FDA's Food Safety Modernization Act. Learn about these major new rules and their compliance triggers in 2017. READ MORE

Is the FSMA a plaintiff’s lawyer’s dream and the food industry’s nightmare?

food processing facility

The FDA's Food Safety and Modernization Act may usher in more than just food safety as compliance deadlines begin to roll out. New mandates focusing on preventive controls, records keeping, food safety plans, menu labeling and much more may also become a boon to consumer lawsuits. READ MORE

Move over GNC: Crackdown on dietary supplement makers continues

Diane Romza-Kutz May 10, 2016

The FDA has renewed its outreach to consumers, educating them on important information and the process to report adverse events. In fact, as recently as March of this year, the FDA posted an updated page on how to spot health care fraud scams directed toward the supplement market. READ MORE

FDA-regulated industries: Plan now for these changes in 2016


Big changes are in store for the industries of animal health, drug, medical devices and tobacco. Among these, the FDA is expected to continue its scrutiny of animal food safety, ramp up its work in post-approval drug studies and keep a close watch on the evolution of mobile medical devices and e-cigarettes. READ MORE

FDA dishes out major regulatory challenges for food industry in 2016


As the FDA continues to intensify its enforcement over its regulated industries, food companies should prepare now to manage their risk by developing and implementing a set of strict compliance programs to avoid enforcement action. READ MORE

GNC lawsuit reflects FDA’s crackdown on dietary supplement industry


The dietary supplement industry, through these FDA enforcement actions, is on notice that its products are under increased national scrutiny, and an internal review of ingredients, labels, and new dietary ingredient filings is well-warranted. READ MORE

FDA promotes safety, control by veterinarians in new Rule: Veterinary Feed Directive


The FDA recently issued other updated regulations, including updating the Veterinary Feed Directive (VFD) regulations regarding VFDs and VFD Drugs (drugs intended for use in conjunction with animal feeds and pet foods). READ MORE

Long-awaited overhaul of FDA food safety rules arrives – Part III: Hazard Analysis and Risk-Based Preventive Controls


The overall focus of this rule requires these plans to continue the FDA’s efforts to ensure the safety of the U.S. food supply and, therefore, each of these plans should be drafted with this in mind. READ MORE

Long-awaited overhaul of FDA food safety rules arrives – Part II: A roadmap for food manufacturers on FDA’s changes to cGMPs


With the passage of the Food Safety and Modernization Act (FSMA), the FDA has created a new and updated set of cGMPs in conjunction with the new Hazard Analysis and Risk-Based Preventative Controls (HARPC) program to correct this lag. READ MORE

Animal supplements still in limbo, facing increased FDA scrutiny


The thousands of food, agriculture and life sciences companies regulated by the federal government already face a barrage of complicated regulations. Add in significant regulatory uncertainty and a major reorganization of the governing agency and you see the current predicament of the animal supplement industry. READ MORE