As the coronavirus (COVID-19) pandemic continues to grow, the US Food and Drug Administration (FDA) on March 18 issued a guidance document titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19...more
The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more
3/16/2020
/ Biotechnology ,
Center for Drug Evaluation and Research (CDER) ,
China ,
Clinical Trials ,
Contingency Plans ,
Coronavirus/COVID-19 ,
Crisis Management ,
Food and Drug Administration (FDA) ,
Imports ,
Infectious Diseases ,
Life Sciences ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Public Health ,
Supply Chain
Welcome to the Q3 2019 issue of our Life Sciences International Review. This issue covers new developments within Europe, Asia, and the United States in intellectual property, regulatory, pricing, and international trade,...more
11/21/2019
/ Asia ,
CFIUS ,
Consumer Privacy Rights ,
Damages ,
EU ,
FIRRMA ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Intellectual Property Protection ,
International Trade Commission (ITC) ,
Life Sciences ,
Medical Devices ,
Patent Litigation ,
Patent Term Adjustment ,
Patent-Eligible Subject Matter ,
Patents ,
Tariffs
EU – REGULATORY -
Brexit, Notified Bodies, and Medical Devices -
The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more
8/20/2019
/ Anti-Kickback Statute ,
Asia ,
China ,
Competition ,
Data Privacy ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
UK Brexit
The US Food and Drug Administration (FDA or the Agency) on June 11 issued the final guidance: “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems” (the ENDS Guidance), which is intended to assist...more
On December 20, President Donald Trump signed the Agriculture Improvement Act of 2018 (Farm Bill), which in part removes hemp and hemp-derived products, including cannabinoids, with less than 0.3% tetrahydrocannabinol (THC),...more
The policy sheds light on risk factors but does not provide inspection predictability. Manufacturers should therefore continue to ensure inspection readiness....more
In a draft guidance document, the US Food and Drug Administration stated that in certain cases, it will allow probiotic products to use colony-forming units to quantify live microbial ingredients on the Supplement Facts...more
As precision medicine gains momentum and in vitro diagnostics (IVDs) become increasingly used in clinical trials, pharma and biotech companies will need to develop expertise in evaluating IVD risk and, if working with IVD...more
FDA final guidance will have significant impact on marketing of biologics, biosimilars and related products.
This month, FDA issued its final guidance on Nonproprietary Naming of Biological Products (Naming Guidance)....more
The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more