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Category Archives: Clinical Studies

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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

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

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part Two of Two

Posted in Biosimilars, Clinical Studies, Drugs, European Union, Generic Drugs, Litigation, Meetings, Rare Diseases

EGA Legal Affairs ForumOn the second day of the 11th Annual Legal Affairs Forum held by the European Generic and Biosimilar Medicines Association, additional exclusivity and intellectual property concerns were covered, including key case updates and strategies (see here for a … Continue Reading