US Stem Cell Inc (USRM)

[a1tellem]

My only post for the day. I made a mistake in my last post. I posted Todd Harrison which is a different lawyer at Venable.

OUR Todd is Todd Halpren. This is Todd. He works for Venable Law firm. They Represent USRM in this battle. He spoke at the Academy of Regenerative Medicine about Adipose stem cells and the FDA. Plenty of FDA experience. Just look at that experience :)

https://www.venable.com/todd-h-halpern/

Bio" Todd Halpern focuses on issues relating to federal and state regulation of companies in the life sciences industry, including manufacturers and marketers of pharmaceuticals, medical devices, food, dietary supplements, and cosmetics. His practice generally covers the laws and regulations administered and enforced by such agencies as the Food and Drug Administration, Drug Enforcement Administration, Federal Trade Commission, and Consumer Product Safety Commission. He has significant experience both proactively counseling business leaders on the risks associated with regulated activities and defending companies accused of regulatory violations.

Todd previously served as Assistant General Counsel, Regulatory Law for Pfizer Inc. As a member of the Chief Regulatory Counsel’s leadership team and lead regulatory attorney to Pfizer Consumer Healthcare, he addressed a variety of issues stemming from the manufacture and promotion of leading over-the-counter brands that include Advil®, Centrum®, Emergen-C®, and Nexium® 24HR. In addition, Todd provided regulatory counsel to Pfizer Global Supply (the company’s manufacturing division), advising colleagues hosting regulatory inspections, responding to FDA Form 483s, and managing other product quality matters arising in the context of private litigation and corporate transactions.

SIGNIFICANT MATTERS
cGMP Compliance – Drugs, Biologics, Dietary Supplements, and Combination Products
Drafting responses to regulatory enforcement letters and agency audit reports (e.g., FDA 483s)
Supporting site management of Board of Health (e.g., FDA) inspections
Addressing questions relating to regulatory notifications (e.g., Field Alert Reports and Biological Product Deviation Reports)
Managing product recalls, including the health hazard assessment, recall strategy, and communications to regulators, customers and the media
Supporting significant transactions involving the acquisition or divestiture of manufacturing sites, including due diligence and issues relating to DEA and state licensing requirements
Negotiating and drafting Quality Agreements
Interpreting new legislation, regulations and FDA policies

DEA Regulation
Drafting corporate standards governing the development of manufacturing site procedures and supporting site management of regulatory inspections
Drafting responses to administrative enforcement letters, and addressing a wide range of issues relating to regulatory compliance

Medical Devices and Mobile Medical Applications
Assessing whether or not proposed technologies are subject to FDA regulation as medical devices
Drafting PMA submission documents
Advising on issues relating to quality system regulations, adverse event reporting, and field actions

Rx to OTC Switch, New Drug Applications, and Drug Safety
Providing key advice on a wide range of issues relating to efforts to obtain FDA approval to switch a drug from prescription to over-the-counter use, such as clinical study compliance, Hatch-Waxman exclusivity, and preapproval communications
Working on complex regulatory matters emanating from drug safety concerns, issues relating to the Pediatric Research Equity Act (PREA), and FDA decisions regarding proposed drug names"

And also @rainmaker RTT brings hope to Myocell, not Adipocell. Time will tell.