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News and Trends Impacting the FDA and Life Science Industry

NYSBA Planning and Networking Event in DC August 9, 2016

Posted in Meetings

Appeals and Issues 4962154 istockAs Chair of the Food, Drug and Cosmetic Section for New York State Bar Association (NYSBA), I wanted to let Members (and member recruits [Note:  NYSBA welcomes lawyers admitted in other states and affiliate members to join –  see here.] know about an upcoming networking event of potential interest that I plan to attend and participate in: Continue Reading

ACI’s 2nd Annual Legal, Regulatory and Compliance Forum on Animal Health

Posted in Animal Drugs, Meetings

ACI Animal Health headerACI is pleased to offer FDA Life readers a 10% discount to attend ACI’s 2nd Annual Legal, Regulatory and Compliance Forum on Animal Health: Veterinary Drugs, Therapeutics, and Animal Food which will take place in New York City on September 13-15, 2016. Use registration code P10-999-FDA17 to receive your 10% discount when you register. To learn more, visit www.AmericanConference.com/AnimalHealth and book your seat today. Continue Reading

Regulatory Enforcement for Food and Beverage Industry Heats Up

Posted in Beverages, Foods, Litigation


Mid-to-late June 2016, federal and state authorities brought a variety of enforcement actions against food and beverage companies under environmental, health, and safety statutes, suggesting increased governmental oversight throughout the supply chain. Continue Reading

Patent Eligibility of Cryopreservation Technique Considered by Federal Circuit

Posted in Litigation, Patents

Court of Appeals for Federal Circuit Snowy Trees Lafayette Park Across from White House Washington DC

On July 5, 2016, the Federal Circuit vacated and remanded a district court decision holding that U.S. Patent No. 7,604,929, which is directed to a method of cryopreservation of hepatocytes (liver cells) was invalid under 35 U.S.C. § 101 because it was directed to a patent-ineligible concept.  In reaching its decision, the Court distinguished recent cases addressing patent eligibility in the biotechnology industry.  The opinion emphasizes that method claims implicating a law of nature are not necessarily patent ineligible, so long as the method is directed to a “new and useful laboratory technique.” Continue Reading

International Council on Harmonisation (ICH) Includes Generic and Biosimilars Trade Organization (IGBA) for the First Time

Posted in Biological Products, Biosimilars, Drugs, European Union, Generic Drugs

ThinkstockPhotos-179040440On June 15, 2016, the International Council for Harmonisation (ICH) (formerly the International Conference on Harmonisation) announced that the International Generic and Biosimilars Medicines Association (IGBA) could join ICH as an Assembly Member.  For the first time, an association representing generic and biosimilar companies is now able to sit at the table with regulators and pharmaceutical companies more traditionally on the innovator spectrum. Continue Reading

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ACI’s FDA Boot Camp – Medical Devices Edition

Posted in Medical Devices, Meetings

ACI FDA Boot Camp Medical Devices EditionAmerican Conference Institute (“ACI”) is holding its fourth annual FDA Boot Camp – Medical Devices Edition on Thursday, July 21, to Friday, July 22, 2016, at the InterContinental Chicago Magnificent Mile, Chicago, Illinois.  This year’s program has been revamped to provide both a “basic training” in FDA regulatory law, as well as “advanced training” sessions tailored to the application of this knowledge to real-life situations. Highlights from this year’s program include: a keynote address from Robin Newman, MSN Ed.D., Director, Office of Compliance, CDRH, a “Ripped from the Headlines” panel, containing updates on key developments in the FDA regulatory bar, and an in-depth Post-Conference Master Class, delving into the hot-button topics of in vitro diagnostics, laboratory developed tests, companion diagnostics, and combination products. McGuireWoods LLP’s own Brian Malkin will be speaking on “High-Risk Devices – Parsing the Premarket Approval Process (PMA)” and “Quality System Regulation.”

You can register for the program here.  FDA Life is a conference media partner, and blog readers can receive 10% off the tuition fee by using discount code [P10-999-FDA17]  when registering for the conference.  A new price tier for the conference will go into effect next week.

FSMA Food Defense Rule Requires Firms to Address Risk of Terrorism

Posted in Foods, Regulation, Risk Management

Risk185953030On May 27, 2016, FDA published its final rule regarding Mitigation Strategies to Protect Food Against Intentional Adulteration (the “Food Defense Rule”). Reflecting an effort to prevent wide-scale public harm through the nation’s food supply from acts of terrorism, the rule will require covered domestic and foreign food facilities for the first time to prepare written food defense plans, ensure that personnel are properly trained, and maintain appropriate records.  The Rule focuses on larger companies whose food products reach greater numbers of people.  Smaller companies and specific sectors of the industry are exempt from the requirements. Continue Reading

EU Rules on Medical Devices Reached Sooner than We Thought

Posted in European Union, Legislation, Medical Devices

iStock_000009370987MediumOn May 25, 2016, the various European Union (EU) negotiators have finally reached a deal (four years in the making) on new rules for medical devices and in vitro diagnostic medical devices (see EU press release here).  This was unexpected and, although formally there are a couple of further procedural steps, companies active in this space should now assume that the rules are final and will be in force in 2016 (but subject to delayed implementation).  In addition to the twenty-eight EU countries, five other countries will be covered by the rules (including Norway, Switzerland, and Turkey). Continue Reading

FDA Updates the Iconic Nutrition Facts Label

Posted in Foods

Food and Beverage

On May 20, 2016, FDA finalized an updated Nutrition and Supplement Facts Label Rule, over two years after proposing several rule updates. This update will require manufacturers to make both visual and substantive changes to their nutrition labels.  Visual changes–including increasing the type size for “calories” and “servings”–may be less onerous for manufacturers than some other new requirements.  Substantive changes range from the declaration of grams and percent daily value for “added sugars” to the required inclusion of grams and daily value percentage of Vitamin D and potassium. Continue Reading

FDA Revisits Nutty Definition of “Healthy” Food

Posted in Foods, Regulation

Engineered foodOn May 10, the Food and Drug Administration announced it will be reevaluating how it defines “healthy” food. The move constitutes a reversal of an FDA warning letter issued in March 2015 to Kind, LLC (“Kind”), accusing the snack bar company of misbranding its KIND products as “healthy,” and falsely labeling some of its fruit and nut snacks as low-fat or rich in antioxidants. Continue Reading