Last week, the U.S. Department of Health and Human Services (“HHS”) announced that FDA intends to update its regulations governing clinical studies of new drugs. More specifically, FDA intends to update Parts 312 and 16 of Title 21 of the Code of Federal Regulations (the “Code” or “CFR”). In its announcement, HHS stated that the revisions will be focused on defining and clarifying “the roles and responsibilities of the various persons engaged in the initiation, conduct, and oversight of clinical investigations subject to [investigational new drug] requirements.” The announcement also notes that the changes will “better protect the rights, safety and welfare of subjects and help ensure the integrity of clinical trial data.”
The Scope of FDA’s Proposed Revisions to the IND Regulations May Not Be Sufficient to Achieve Its Stated Goals
Congratulations to Chad E. Oswald on graduating from Bar Leader Series Class of XIII. The IndyBar’s Bar Leader Series develops lawyers for future opportunities in leadership roles in the business and legal communities. Through the Bar Leader Series, participants learn what it means to be a leader, gain insight vital to leaders in our community and learn how to communicate, motivate, inspire and succeed not only in their law career, but also in service to professional, political, judicial, civic and community organizations.
Each year, Harrison & Moberly, LLP, Indianapolis Monthly magazine and Marti Starkey sponsor the Starkey Entrepreneurial Woman Award, which honors an outstanding female business owner who exhibits courage, tenacity and selflessness in starting and running her own business. The Award is given each year at the annual Awards Breakfast, held this year on May 6 at the beautiful Meridian Hills Country Club. Entrepreneurial Spirit Awards Winners are also selected and given an award for exhibiting courage, tenacity and selflessness in an endeavor.
President Barack Obama on May 11, 2016 signed the Defend Trade Secrets Act (DTSA), which provides a federal private right of action for the misappropriation of trade secrets. Companies were previously only able to bring civil actions for trade secret protection in state court under various state laws. Under the new law, trade secret owners can pursue claims in federal court and apply for an order to seize property to prevent the dissemination of trade secrets. The DTSA also provides for remedies including injunctive relief and damages for actual loss, unjust enrichment and a reasonable royalty amount.
Royal Oak, Michigan, May 25, 2016: Howard & Howard Attorneys PLLC is pleased to announce that Andrew (Jake) Grove has joined the firm. He will practice out of the firm’s Royal Oak Office.
Jake Grove, who concentrates his practice in patent, trademark, copyright and trade secrets matters, brings nearly 27 years of experience in intellectual property law, including several assignments as lead counsel in complex IP litigation matters for some of the largest companies in the world. Grove has experience preparing and prosecuting patent and trademark applications with an emphasis on mechanical and electro-mechanical technologies and assists clients in finding cost-effective resolutions to patent troll attacks. One of the premier IP litigators and IP law thought leaders in the area, Grove has a long-term professorship at the University of Detroit Mercy Law School, several published works including a student case book on patent law, and is a regular speaker at a wide variety of conferences.
Phase II of the HIPAA Audit Program has begun, with many covered entities and business associates receiving a “Audit Entity Contact Verification” message from the Department of Health and Human Services (HHS) and the Office of Civil Rights (OCR). The communication requires the individual recipient to verify that he or she is the primary contact […]
Daria Pustilnik, a business litigation associate in our West Palm Beach office, was named a member of the 211 Palm Beach/Treasure Coast Board of Directors. 211 is a community helpline and crisis hotline that provides suicide prevention, crisis intervention, information, assessment and referral to community services for people of all ages.
211 Palm Beach/Treasure Coast provides services for individuals and families living in Indian River, Martin, Okeechobee, Palm Beach and St. Lucie counties. Calls are free, confidential and available 24 hours a day, 365 days per year.
Rodriguez is a registered patent attorney with the U.S. Patent and Trademark office. He handles patent, trademark and copyright litigation matters and serves businesses and individuals in procuring and protecting their intellectual property. Rodriguez prosecutes U.S. and foreign patent applications for a wide range of technologies, including wireless communications, computer networking, cloud computing, software applications, electrical circuits and business methods.
Record revenues of $147 million boosted Florida business law firm Shutts & Bowen LLP seven spots in The Am Law 200 ranking, rising to Number 168, with revenues of $147 million and more than 270 attorneys throughout Florida.
“Revenue increased 8 percent in 2015, with matters coming to the firm being increasingly larger and more sophisticated,” Executive Committee Chairman Bowman Brown said.
Our colleagues Joshua Stein, co-chair of Epstein Becker Green’s ADA and Public Accommodations Group, and Stephen Strobach, Accessibility Specialist, have a post on the Retail Labor and Employment Law blog that will be of interest to many of our readers in the hospitality industry: “DOJ Refreshes Its Efforts to Promulgate Title II Website Accessibility Regulations and Other Accessible Technology Updates – What Does It All Suggest for Businesses?”