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Category Archives: Biological Products

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Susan Winckler Featured Keynote Speaker This Week at 8th Annual Pharmaceutical and Medical Device Conference in Chicago on November 10

Posted in Advertising and Promotion, Animal Drugs, Antitrust, Biological Products, Clinical Studies, Drugs, Emerging Growth, Enforcement, European Union, FDA Organization, Healthcare, Intellectual Property, Legislation, Litigation, Medical Devices, Meetings, Patents, Regulation

159161119On November 10, 2016, McGuireWoods LLP and McGuireWoods Consulting (“McGuireWoods”) will be holding its 8th Annual Pharmaceutical and Medical Device Conference in Chicago.  Kicking off the Conference will be Keynote Speaker, Susan Winckler, the Chief Risk Management Officer for Continue Reading

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.

Topics

  • Executive Roundtable – Life Sciences Industry Update
  • FDA Update – Recent Developments and
Continue Reading

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 … 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 … Continue Reading

Biological/Biosimilar Nonproprietary Naming Guidance and Proposed Rule for Certain Proposed Nonproprietary Names for Previously-Approved Biological Product Names Published

Posted in Biological Products, Biosimilars, Guidance

ThinkstockPhotos-457742249On August 27, 2015, FDA released a long-awaited draft guidance entitled “Nonproprietary Naming of Biological Products” (the “Draft Guidance”). The Draft Guidance sets forth a naming convention for all biological products – both those previously approved and those … Continue Reading

Biomanufacturing Technology Summit 2015 in Maryland: Bioanalytics Guiding Quality, Where Increased Collaboration Could Lead to Faster and Greater Discoveries

Posted in Biological Products, Biosimilars, Meetings

ThinkstockPhotos-188078261On June 25, 2015, the Institute for Bioscience and Biotechnology Research (IBBR), the National Institute of Standards and Technology (NIST), and the University of Maryland (UM) put on its second Biomanufacturing Technology Summit, “Manufacturing Science Analytics: Predictors of Biotherapeutic Product … Continue Reading

FDLI’s Annual Conference Next Week – April 20 and 21 in Washington, D.C. – Special Reader Discount

Posted in Animal Drugs, Biological Products, Drugs, Foods, Medical Devices, Meetings, Tobacco Products

FDLILogoMcGuireWoods is an official Media Partner for the Food and Drug Law Institute’s (FDLI’s) Annual Conference. As the largest and longest-running legal conference for the entire food and drug law community, including every product category regulated by FDA, you won’t … Continue Reading

FDLI Annual Conference April 20-21, 2015 – Registration Discount for FDA Life Readers

Posted in Animal Drugs, Biological Products, Drugs, FDA Organization, Foods, Medical Devices, Meetings, Tobacco Products

FDLILogoMcGuireWoods is an official Media Partner for the Food and Drug Law Institute’s (FDLI’s) Annual Conference.  FDLI’s Annual Conference is the largest and longest-running legal conference for the entire food and drug law community, including every product category regulated by … Continue Reading

11th Legal Affairs Forum in Brussels, Belgium on March 26-27, 2015

Posted in Biological Products, Biosimilars, Drugs, European Union, Generic Drugs, Intellectual Property, Litigation, Meetings, Patents

EGA Legal Affairs ForumOn March 26-27, 2015, the European Generic and Biosimilar Medicines Association (EGA) will host its 11th Legal Affairs Forum in Brussels, Belgium. The Forum will focus particularly on:

–       EGA 2020: Where Are the Latest Trends Leading this Sector?

A … Continue Reading

McGuireWoods’ Brian Malkin Speaks on Biosimilars Patent Litigation at EGA’s Legal Affairs Forum in Brussels on March 27, 2015

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

EU buildingOn March 27, 2015, McGuireWoods’ Brian J. Malkin will be speaking on “Biosimilars Patent Litigation” at the European Generic Medicines Association’s (EGA’s) Legal Affairs Forum in Brussels, Belgium. The Legal Affairs Forum highlights trends in the generic sector leading to … Continue Reading

FDA/CMS Summit Demonstrates Increasing Importance for Parallel Review Considerations and Ongoing FDA and CMS Reform – Part 2 of 2

Posted in Biological Products, Biosimilars, Drugs, Healthcare, Medicare, Meetings, Reimbursement

On December 11-12, 2014, Informa Business Information, Inc. presented its 10th Annual FDA/CMS Summit.  The Summit delivered presentations from key leaders in both the FDA and Centers for Medicare and Medicaid (CMS) sectors with many thought-provoking discussions.  Some of those Continue Reading

FDA/CMS Summit Demonstrates Increasing Importance for Parallel Review Considerations and Ongoing FDA and CMS Reform – Part 1 of 2

Posted in Biological Products, Drugs, Healthcare, Medicare, Meetings, Reimbursement

On December 11-12, 2014, Informa Business Information, Inc. presented its 10th Annual FDA/CMS Summit.  The Summit delivered presentations from key leaders in both the FDA and Centers for Medicare and Medicaid (CMS) sectors with many thought-provoking discussions.  Some of those Continue Reading