Recent developments in international privacy laws have complicated the conduct of clinical trials outside of the United States. Since the privacy law of the European Union – the General Data Protection Regulation or “GDPR” –...more
9/20/2021
/ Brazil ,
Clinical Trials ,
Data Collection ,
Data Protection ,
EU ,
General Data Protection Regulation (GDPR) ,
Healthcare ,
Japan ,
Life Sciences ,
Medical Research ,
Nigeria ,
Personal Data ,
Personally Identifiable Information ,
Privacy Laws ,
Singapore ,
South Africa ,
South Korea
Recognizing the impact that COVID-19 can have on research and the NIH grant application process, the NIH has issued 5 pieces of guidance between March 9 and 16, 2020 addressing various impacts of COVID-19 on NIH research...more
The FDA this month released guidance surrounding the conduct of clinical trials involving medical products during the COVID-19 pandemic.
The key themes of the guidance are (i) protect the health and safety of trial staff...more
Recognizing the impact that COVID-19 can have on research and the NIH grant application process, the NIH has issued 5 pieces of guidance between March 9 and 16, 2020 addressing various impacts of COVID-19 on NIH research...more
It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more
7/17/2018
/ 21st Century Cures Act ,
Affordable Care Act ,
Client Services ,
Depositions ,
DQSA ,
Emergency Response ,
Enforcement Actions ,
FDASIA ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
Innovation ,
Juror ,
Jury Trial ,
Law Firm Associates ,
Law Firm Ownership ,
Law Firm Partners ,
Law Practice Management ,
Manufacturers ,
Medical Device User Fee Program (MDUFA IV) ,
Medical Devices ,
Multidistrict Litigation ,
Patient Rights ,
Patient Safety ,
Patients ,
Pharmaceutical Industry ,
Preemption ,
Questionnaires ,
Reporting Requirements ,
State Law Tort Claims ,
Voir Dire ,
Witness Preparation
Every summer vacation (or, at least, the ability to take the weekend off!) should include a good read. Whether your preference runs toward a memoir with words of wisdom, a review of new technical advancements, issues of...more
10/19/2017
/ BNSF Railway Co v Tyrrell ,
Bristol-Myers Squibb Co v Superior Court of California - San Francisco County ,
Crowdsourcing ,
Depositions ,
Genetic Materials ,
Jurisdiction ,
Litigation Strategies ,
Pharmaceutical Industry ,
Physicians ,
R&D ,
TC Heartland LLC v Kraft Foods ,
Testimony ,
Venue