By Colleen Sproul on February 29, 2012
As we have recently experienced an unexpected amount of “push back” from our client clinical sites on the requirement that sponsors have access to the social security number of study subjects that are Medicare beneficiaries if a sponsor makes payments to site and/or study subjects for research-related injuries, I thought it might be helpful to [...]
Posted in Blog Updates | Tagged Compliance, Informed Consents
By Colleen Sproul on October 30, 2011
Contracts Associates is looking for another experienced Life Sciences attorney consultant to add to our team. Ideal candidate will be available 40 hours a week to work virtually with some on site work as needed. Responsibilities include managing and overseeing preparation, negotiation, and execution of day-to-day pharmaceutical corporate contracts including without limitation, US and ex-US [...]
Posted in Blog Updates
By Colleen Sproul on September 2, 2011
Health reform legislation included a new industry-wide fee on branded prescription drugs, based on a manufacturer’s share of the government drug sales market, defined as Medicaid, Medicare Parts B and D, Veterans Administration (VA), Department of Defense (DOD) and TRICARE retail pharmacy purchases. This annual fee, administered by the Internal Revenue Service, will be imposed [...]
Posted in Blog Updates
By Colleen Sproul on August 10, 2011
The above is the title of an upcoming seminar sponsored by the Food and Drug law Institute and, in a nutshell, the speaker’s opinion is an unequivocal “there should be no effect at all”. The promotional flyer I received has the following synopsis: “(the) FDA should resist the temptation to allow cultural fears to influence [...]
Posted in Blog Updates
By Colleen Sproul on June 3, 2011
On May 25, 2011, the SEC issued final rules to implement the whistleblower provisions enacted as part of the Dodd-Frank Act. These provisions authorize the SEC to award substantial monetary bounties to individuals who provide original information to the SEC that leads to enforcement actions resulting in the collection of more than $1,000,000 in monetary [...]
Posted in Blog Updates
By Colleen Sproul on April 18, 2011
The European Commission is moving forward with its two legislative proposals for a single European patent which, it says, will reduce the cost of patents in Europe by up to 80%. Presently, the European Patent Office (EPO) grants patents but the inventor has to then request validation from each individual EU country in which he/it [...]
Posted in Blog Updates | Tagged EU, Patent
By Colleen Sproul on January 4, 2011
Effective March 7, 2011: Sponsors who register their clinical studies on ClinicalTrials.gov must disclose such registration on the applicable study subject informed consents with the following language: “A description of this clinical trial will be available on http://www.Clinical Trials.gov, as required by U.S. Law. This Web site will not include information that can identify you. [...]
Posted in Blog Updates | Tagged Clinical Trial Agreements, Informed Consents, Regulatory
By Colleen Sproul on December 29, 2010
We visit NYC several times a year for conferences and client visits and we take a lot of taxi rides while we are there. Last August, during one such trip, a NYC cabdriver was stabbed by a passenger and the story of his family, struggling to cope with his injuries and the costs of caring [...]
Posted in Blog Updates
By Colleen Sproul on December 11, 2010
We gave two presentations a day on this trip and the companies were at least an hour’s drive from each other. It was a real grind but the people at ICBio, Lotus Labs, Natural Remedies, and Micro Labs Ltd were a pleasure and my colleagues, Virkam and Birjit were great company. Not only was [...]
Posted in Blog Updates
By Colleen Sproul on December 8, 2010
Shilpa Jangam, one of our Bangalore-based legal consultants, and I had the opportunity to visit Lotus Labs yesterday. We spent a few hours as the guests of Dr. Yati Church, the managing director, and Prasad Rao, Lotus’ Senior Manager, Business Development. It was a unique opportunity for us attorneys to see what exactly transpires in [...]
Posted in Blog Updates | Tagged India, Phase I