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FDA Life

News and Trends Impacting the FDA and Life Science Industry

McGuireWoods 8th Annual Pharmaceutical and Medical Device Conference in Chicago on November 10

Posted in Biological Products, Drugs, Medical Devices, Meetings

159161119Join us for an interactive conference addressing key legal and business matters focusing on innovation, investing, and regulatory issues in the pharmaceutical and medical device sectors.


  • Executive Roundtable – Life Sciences Industry Update
  • FDA Update – Recent Developments and New Initiatives Impacting Pharmaceutical and Medical Device Companies
  • HCP Relationships and Enforcement Issues
  • Brexit Update
  • Financing Alternatives for Life Sciences Companies
  • Business and Legal Issues for Early-Stage Companies
  • Patent Prosecution and Litigation Issues for Life Sciences Companies
  • Hot Button ‎Antitrust Issues for Life Science Companies
  • Business and Legal Issues in Clinical Research Arrangements
  • Company Presentations

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Regulatory Misconduct Reporting Hits Hits CDRH’s Website – Plus Upcoming FDA Public Hearing On Off-Label Communications

Posted in Advertising and Promotion, Enforcement, Medical Devices, Meetings

Healthcare False ClaimsOn October 21, 2016, at the end of the week of AdvaMed 2016, FDA’s Center for Devices and Radiological Health (CDRH) unveiled its new page, “Reporting Allegations of Regulatory Misconduct.”  According to the new page: Continue Reading

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U.S. Biosimilars Market Future – Forum in D.C. on October 18, 2016

Posted in Biosimilars, Meetings

ThinkstockPhotos-166840573On October 18, 2016, the Friends of Cancer Research and the Duke-Margolis Center for Health Policy will convene a half-day forum bringing together clinicians, originator and biosimilar drug sponsors, advocates, regulators, and payers to tackle remaining uncertainty surrounding the future of the U.S. biosimilars market.  The Forum, “The Future of the U.S. Biosimilars Market: Development, Education, and Utilization” will be held in Washington, D.C. at the Washington Marriott – Georgetown, 1221 22nd Street, NW. Continue Reading

Medical Marijuana in New York – NYSBA CLE on October 14, 2016 in NYC

Posted in Drugs, Healthcare, Meetings
New York CityOn October 14, 2016, the New York State Bar Association’s (NYSBA’s) Health Law Section, Food, Drug and Cosmetic Law Section, and Committee on Continuing Legal Education (CLE) in conjunction with the PULSE Center for Patient Safety Education & Advocacy, will be holding a live and Webcast program on “Medical Marijuana in New York 2o16” in New York City.  McGuireWoods LLP’s Brian Malkin is the Chair of NYSBA’s Food, Drug and Cosmetic Law Section.  Bethany Hills, Executive Committee Member of the Food, Drug and Cosmetic Law Section, plans to attend the CLE program and will be available to answer questions about the Section.

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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