On 30 July 2021, the FAR Council published a proposed rule to significantly strengthen “Buy American” requirements applicable to goods sold to the U.S. Government. The proposed rule promotes the procurement of goods,...more
8/4/2021
/ Biden Administration ,
Buy America ,
Buy American Act ,
Buy American and Hire American ,
Department of Defense (DOD) ,
Executive Orders ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Made in the USA ,
Manufacturers ,
Proposed Rules ,
Public Meetings ,
Supply Chain
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
On 18 May 2020 the U.S. Court of Appeals for the Ninth Circuit ruled against the National Collegiate Athletic Association (NCAA) in an antitrust case challenging the association's policy of limiting the compensation paid to...more
On April 8, the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) issued guidance discussing how HHS human subjects protection regulations....more
As the world responds to COVID-19, physicians and patients increasingly turn to telemedicine solutions as a central facet of health care. ...more
The COVID-19 pandemic has sparked renewed interest in offering online programs, both in the United States and internationally, as a means for students to continue their studies on an uninterrupted basis. The U.S. Department...more
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time.
...more
3/25/2020
/ Adverse Events ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
EU ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Regulatory Oversight ,
REMS
On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic."...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
3/17/2020
/ Biopharmaceutical ,
Biotechnology ,
Centers for Disease Control and Prevention (CDC) ,
China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Italy ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Netherlands ,
Public Health ,
Reimbursements ,
Research and Development ,
Supply Chain ,
Travel Restrictions ,
Trump Administration ,
UK ,
Vaccinations ,
Vendors ,
World Health Organization
On 5 March 2020, the U.S. Department of Education (ED) published an electronic announcement to provide guidance on compliance with federal student financial aid (Title IV) requirements in connection with students for whom...more
3/10/2020
/ Best Practices ,
China ,
Colleges ,
Coronavirus/COVID-19 ,
Department of Education ,
Educational Institutions ,
Emergency Management Plans ,
Health and Safety ,
Infectious Diseases ,
New Guidance ,
Policies and Procedures ,
Public Health ,
Risk Management ,
Students ,
Title IV ,
Universities
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
2/26/2020
/ 3D Printing ,
AIDS ,
Analytics ,
Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Blockchain ,
California Consumer Privacy Act (CCPA) ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Defense (DOD) ,
Digital Health ,
Drug Distribution ,
Drug Pricing ,
EU ,
Federal Funding ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Technology ,
HIV ,
Incident Response Plans ,
Intellectual Property Protection ,
Life Sciences ,
Medical Device Data System ,
Medical Devices ,
Medical Software ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Procurement Guidelines ,
Regulatory Standards ,
Research and Development ,
Right to Try ,
Robotics ,
Supply Chain ,
Telehealth
International engagement continues to define modern higher education. Despite recent concerns about foreign influences on United States education and research, cross-border contracts continue apace. Complex agreements with...more
On 17 December 2019, the U.S. Department of Education (ED) published in the Federal Register notice of a new information collection request (ICR) related to reporting requirements under Section 117 of the Higher Education Act...more
12/31/2019
/ Department of Education ,
Disclosure Requirements ,
Education Reform ,
Educational Institutions ,
Gifts ,
Higher Education Act ,
Information Management ,
New Regulations ,
OMB ,
Regulatory Requirements ,
Reporting Requirements
Two recent antitrust investigations by the U.S. Department of Justice (DOJ) into student recruitment practices highlight the agency's increased interest in higher education. These investigations are the latest in a number of...more
Our team in Hong Kong recently developed a Hong Kong Law Contract Guide. The guide discusses relevant legal principles that inform the most common contractual clauses in Hong Kong. The guide offers practical points to...more
11/13/2019
/ Arbitration ,
Consent ,
Contract Drafting ,
Contract Formation ,
Contract Termination ,
Contract Terms ,
Damages ,
Hong Kong ,
Jurisdiction ,
Legal Project Management ,
Legal Representatives ,
Limitation of Liability Clause ,
Privity of Contract ,
Representations and Warranties ,
Waiver of Liability
Higher education institutions increasingly leverage P3s to deliver campus projects, including with respect to energy and utility assets, instead of traditional project structures that involve the institution owning and...more
10/18/2019
/ Carbon Emissions ,
Colleges ,
Construction Project ,
Educational Institutions ,
Electricity ,
Energy Efficiency ,
Infrastructure ,
Project Finance ,
Public Private Partnerships (P3s) ,
Public Projects ,
Real Estate Development ,
State and Local Government ,
Universities ,
Urban Planning & Development
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
3/18/2019
/ Artificial Intelligence ,
Asia ,
Biologics ,
Biotechnology ,
Data Breach ,
Digital Health ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
"Capacity development is the process through which individuals, groups and organisations, and societies deploy, adapt, strengthen, and maintain the capabilities to define, plan, and achieve their own development objectives on...more
On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” ...more
Thanks to the rapid development and widespread acceptance of online programs over the last decade, American universities and their respective business partners now offer degree or non-degree programs entirely online around...more
7/10/2018
/ Accreditation ,
Continuing Education ,
Data Privacy ,
Data Security ,
For Profit Education ,
Global Marketplace ,
Higher Education Act ,
Online Education ,
Regulatory Oversight ,
Regulatory Requirements ,
Tax Liability
On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). ...more
5/25/2018
/ Biotechnology ,
Clinical Trials ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Institutional Review Board (IRB) ,
Life Sciences ,
Office for Human Research Protections (OHRP) ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements ,
Research and Development
The Fourth Industrial Revolution is upon us and countries across the world are grappling with ways to capitalize on its opportunities and mitigate its risks....more
In February of this year, we reported a new tax development in China (Bulletin 11) affecting Sino-foreign cooperative education institutions and programs. Bulletin 11 came into effect on 1 April 2018, amongst ambiguity about...more
Last month, Chinese tax authorities issued a groundbreaking tax notice (Bulletin 11). As a result, foreign universities operating in China will be subject to a new tax regime effective 1 April 2018, including more than 1,000...more
The emerging education market in Vietnam is attracting interest from foreign higher education institutions and investors. Increasing disposable income, rapid urbanization, and rising living standards are driving local demand...more