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
Ongoing Effort to Harmonize Human Subject Research Regulations The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS),...more
10/5/2017
/ 21st Century Cures Act ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Institutional Review Board (IRB) ,
Meeting Minutes ,
Office for Human Research Protections (OHRP) ,
Regulatory Oversight ,
Regulatory Reform ,
Research and Development ,
The Common Rule
On July 25, 2017, FDA issued a guidance document describing under what circumstances IRBs may now approve consent procedures that waive or alter some or all of the elements of informed consent as set forth in FDA’s informed...more
On March 27, the Middle States Commission on Higher Education (“Middle States”) released for public comment a draft policy on its expectations for honesty and truthfulness in published information and in student recruitment...more
On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the...more
2/13/2017
/ 21st Century Cures Act ,
Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biotechnology ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
IRB ,
NPRM ,
Scientific Research ,
The Common Rule