The CMS rule the establishes a new coverage pathway – MCIT – for breakthrough medical technologies.
On Tuesday, January 22, 2019, the U.S. Supreme Court held in a unanimous decision that, even where the details of the invention are kept confidential, a commercial sale may place the invention “on sale” under the Leahy-Smith America Invents Act (“AIA”). Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.Continue reading
Staying abreast of regulatory changes can be a game changer for your businessContinue reading
The inter partes review process for challenging the validity of patents at the U.S. Patent Office
This presentation was recorded on August 14, 2018 as part of the Legal Lunch series hosted for AZBio by Perkins Coie.Continue reading
The 2016 Health Technologies Resource Report is now LIVE and filled with country by country data and analysis that can help you grow your business. This market intelligence is a FREE resource if the U.S. Commercial Service.
It’s been nearly five years since drug makers and other in the industry were promised FDA-approved guidelines as a part of the Prescription Drug User Free Act (section 1121.) For many drug companies, the lack of guidelines has hindered their marketing outreach due to fear that any participation in social media (or online advertising for that matter) could result in fines or penalties based on unclear policy and regulation. This week, the FDA released a 10-page document that outlined the first in what promised to be more concise guidelines for the industry, which are due in July of this year as a part of the 2012 FDA Safety and Innovation Act (FDASIA) which requires the agency to “issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products” that it regulates. The bulk of the drafted guidelines still focuses on the POSTmarketing requirements that have long been in question with regard to social media and online advertising. Continue reading
DNASU distributes plasmids to researchers worldwideContinue reading