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News and Trends Impacting the FDA and Life Science Industry

FDAnews Expanded Access Briefing Features FDA, Industry, Patient Advocates, and Academia at McGuireWoods DC

Posted in Biological Products, Clinical Studies, Drugs, Medical Devices, Meetings, Regulation

McGuireWoods DCOn October 13, 2016, FDAnews is hosting its first in-person briefing at McGuireWoods LLP’s DC Office with the topic: “Expanded Access: FDA’s New Regulatory Process How Compassionate Use Fits into Proposed Reforms“.  The Briefing brings together key representatives from FDA, Industry, Patient Advocacy, Academia, and the Hill in a unique setting to comprehensively address FDA’s latest thinking on expanded access / compassionate use programs and how the 21st Century Cures Act and other bills being considered in Congress may affect those programs going forward.  The Briefing features as its Keynote Speaker, Richard Klein, Director, Patient Liaison Program, Office of Health and Constituent Affairs, Office of the Commissioner, FDA, a nationally-recognized speaker on FDA’s expanded access programs.  McGuireWoods LLP’s Brian Malkin and Kate Hardey will moderate the program, and McGuireWoods LLP is hosting the reception that follows the program.   Continue Reading

ACI’s 2nd Annual Legal, Regulatory and Compliance Forum on Animal Health, September 13-15, 2016 in NYC

Posted in Animal Drugs, Meetings

ACI Animal Health LogoACI has expanded this unique, one of a kind event designed for lawyers and regulatory executives who work for the animal health industry to include coverage of animal foods and feeds in addition to drugs and medicines. ACI’s Animal Health conference will provide you with state of the union updates in addition to in-depth discussions on some of the industry’s most perplexing challenges. Continue Reading

REMS and Restricted Drug Distribution – FDA Regulatory and Antitrust Program Sponsored by NYSBA

Posted in Antitrust, Drugs, Legislation, Litigation

New York CityOn November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, will put on a program in New York City: “REMS and Other Drug Distribution Restrictions: When Does a Brand Company Have a Duty to Deal with its Generic Rivals?”  The program will be held from 6:00-9:00 pm with a reception (cocktails and hors d’oeuvres) to follow.   The speakers below feature both federal and state antitrust lead attorneys working on these issues, as well as counsel for both reference and generic applicants, to provide for a lively and informative discussion and dialog. Continue Reading

NYSBA Non-Resident Attorney Member Networking Event in DC TONIGHT!

Posted in Meetings


washington-dcAs a member of the New York State Bar’s (NYSBA’s)  Subcommittee on Non-Resident Members, I wanted to send out a reminder for tonight’s networking event in D.C.   Unlike some other bar associations, NYSBA welcomes lawyers admitted in other states and affiliate members to join –  see here.  I plan to attend and participate in this event, described below. Continue Reading

ACI Medical Devices Boot Camp Features New CDRH Director of Compliance Robin Newman

Posted in Medical Devices, Meetings

Close-up of a military soldier tightening and tying the left boot.On July 21-22, the American Conference Institute (ACI) held its Fourth Annual FDA Boot Camp: Medical Devices Edition in Chicago, Illinois. The conference provided both basic and advanced training in core regulatory concepts for medical devices.  McGuireWoods LLP’s Brian Malkin presented on “High-Risk Devices – Parsing the Premarket Approval Process (PMA)” and “Quality System Regulation”. Continue Reading

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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