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News and Trends Impacting the FDA and Life Science Industry

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

McGuireWoods’ Brian Malkin to Conduct Off-Label Promotion Discussion at FDLI’s Annual Meeting on May 5 in Washington, D.C.

Posted in Advertising and Promotion, Meetings

FDLILogoOn May 5, 2016, McGuireWoods LLP’s Brian Malkin will conduct an exclusive discussion at the Food and Drug Law Institute’s (FDLI’s) Annual Meeting in Washington, D.C.  New this year to the Annual Meeting, FDLI will conduct a variety of lunch table discussions from 12:30-1:30 p.m.  Malkin will host a table called “Amarin” to discuss off-label communications in view of the recent cases Caronia, Amarin, Pacira and more.  Following the Amarin decision, Malkin moderated a FDLI Webinar, “Amarin and the Future of Off-Label Promotion“.  Malkin has followed the issue for not only drug products, but also for medical devices, where he later spoke on “Off-Label Promotion in the Wake of the Amarin Decision” at McGuireWoods LLP’s own 7th Annual Medical Device and Life Sciences Conference. Continue Reading

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Advertising Claims for Over-the-Counter, Cosmetic, and Dietary Supplements in NYC on May 26, 2016

Posted in Advertising and Promotion, Cosmetics, Dietary/Nutritional Supplements, Drugs, Meetings

New York CityOn May 26, 2016, the Cosmetic Law Committee and Food Law Committee of the Food, Drug and Cosmetic Law Section of the New York State Bar Association will present an expert panel of private practitioners, in-house counsel, and staff attorneys of the ASRC National Advertising Division (NAD) program administered by the Council of Better Business Bureaus to discuss the NAD’s self-regulatory program for challenging deceptive and unsubstantiated advertising claims, and analyze recent and noteworthy NAD challenges and decisions regarding advertising claims for over-the-counter (OTC) drugs, cosmetics, and dietary supplement products. Continue Reading

Danish Biotech Conference at McGuireWoods LLP’s New York City Office on April 12-13, 2016

Posted in Biological Products, Meetings

ThinkstockPhotos-178705804On April 12-13, 2016, McGuireWoods LLP‘s New York City Office will host a special Danish Biotech Conference featuring nationally-renowned speakers on topics concerning investors in Danish biotechnology companies, as well as one-on-one sessions with Danish biotechnology companies.  McGuireWoods LLP’s Seth Goldsamt, Stephen Older, and Brian Malkin will speak on or introduce the following panels:  “Welcome and Introduction” (Goldsamt), “Demystifying the US IPO Process” (Older), and “Navigating the FDA: Positioning for Orphan Drugs, Special Assessments, and Breakthrough Designations” (Malkin).  McGuireWoods Consulting’s Stephanie Kennan and Charlie Iovino will speak on the panel “Understanding Pricing and Reimbursement; Building a Strategy”.  Other panels feature speakers from Avalere Health, NASDAQ, Citibank, BDO USA, LLP, FBR Capital Markets & Co., Venrock, Aisling Capital, Omega Funds, 5AM Ventures, Pfizer, Inc., DYAX Corp., Johnson & Johnson Innovation LLC, and Pharmakon Advisors and include:

  • Fireside Chat with Ole Larsen, CFO, Bavarian Nordic
  • NASDAQ: Ringing of Marketing Opening Bell
  • Investor Prospectives Through the Lifecycle
  • Working with Pharma: Collaborations to Buyout.

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McGuireWoods LLP’s Brian Malkin Quoted in Law360 Article on FDA’s New Stance on Opioid Drugs

Posted in Drugs, Risk Management

antibioticsOn March 28, 2016, McGuireWoods LLP’s Senior Counsel Brian J. Malkin was quoted in a La360 article, “New FDA Rules Put Onus On Doctors To Curb Opioid Abuse.”  discusses the U.S. Food and Drug Administration’s new requirement for “black box” warnings on immediate-release opioids, intended to alert patients to potential risks of “misuse, abuse, addiction, overdose and death.” Malkin was quoted indicating that a black box warning is perceived as the “kiss of death” because it means drug companies must bring up the subject of the warning almost immediately when discussing the drugs. The full text of this article is available to subscribers online.