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News and Trends Impacting the FDA and Life Science Industry

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

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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.”

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IGBA and Medicines for Europe Hold Joint Annual Meeting in Dubrovnik, Croatia, in June 2016 – Part 2 of 2

Posted in Biosimilars, European Union, Generic Drugs, Meetings

croatiaThis is a continuation of coverage of the International Generic and Biosimilars Association (IGBA) (formerly known as the International Generic Pharmaceutical Alliance (IGPA)) and Medicines for Europe (formerly known as the European Generic and Biosimilars Association (EGA)) joint 19th IGBA Annual Program and 22nd Medicines for Europe Annual Conference held on June 8-10, 2016 in Dubrovnik, Croatia.  For the first part of this coverage, see here. Continue Reading

IGBA and Medicines for Europe Hold Joint Annual Meeting in Dubrovnik, Croatia, in June 2016 – Part 1 of 2

Posted in Biosimilars, European Union, Generic Drugs, Meetings

croatiaOn June 8-10, 2016, the International Generic and Biosimilars Association (IGBA) (formerly known as the International Generic Pharmaceutical Alliance (IGPA)) and Medicines for Europe (formerly known as the European Generic and Biosimilars Association (EGA)) held a joint 19th IGBA Annual Program and 22nd Medicines for Europe Annual Conference—the first joint conference of these revamped groups—in Dubrovnik, Croatia, with one of the largest attendance of over 300 participants. Continue Reading