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Category Archives: Drugs

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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.


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

European Commission Seeking Comments on Draft Text Laying Out the Safety Features to Appear on Pharmaceutical Packaging

Posted in Drugs, European Union, Labeling

EU building (vertical)On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human use. The EUDA was a response … Continue Reading

Challenge to FDA Therapeutic Equivalence Down-Rating Denied as Not Final Agency Action for Now

Posted in Drugs, Litigation

Pharmaceutical Patent Litigation (ANDA) 122530349On July 29, 2015, the District of Maryland Judge Deborah Chasanow denied Mallinckrodt Inc.‘s (“Mallinckrodt’s”) attempt to obtain judicial review of FDA’s determination that its methylphenidate hydrochloride extended-release tablets ANDA referencing Janssen Pharmaceutical Inc.’s Concerta® (“Mallinckrodt’s ANDA”) would be … Continue Reading

Abilify®’s Saga Continues: Otsuka’s Eight-Day Streak of Generic-Free Competition Ends, For Now

Posted in Antitrust, Drugs, Generic Drugs, Litigation, Rare Diseases

antibioticsOn May 27, 2015, the U.S. District Court for the District of Maryland granted FDA and the Defendant-Intervenors summary judgment against Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”), holding that … 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

Otsuka Files Amended Complaint and Motion for TRO/PI for Abilify®, Pointing to Congressional Intent to Argue Broad Exclusivity

Posted in Drugs, Labeling, Litigation, Rare Diseases

antibioticsAs discussed in our April 13, 2015 blog, Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America Pharmaceutical, Inc. (collectively “Otsuka”) had until April 15, 2015 to file an amended complaint and a temporary restraining … Continue Reading