In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary supplements, and other products...more
The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more
4/5/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Drug Distribution ,
Federal Loans ,
Financial Stimulus ,
Food Manufacturers ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Prescription Drugs ,
Relief Measures ,
Small Business ,
Suppliers
In light of the hand sanitizer shortage during the coronavirus (COVID-19) pandemic, many manufacturers are seeking alternative sources of alcohol for incorporation into their hand sanitizer products. The need for alcohol has...more
In light of the hand sanitizer shortage during the coronavirus (COVID-19) emergency, many companies have been trying to find alternative sources of product, especially employers in healthcare and essential service sectors...more
With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact...more
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
Autonomous cars, sports betting, and CBD products have burst onto the scene, setting the stage for major developments in how companies do business and how regulators monitor new innovations....more
2/10/2020
/ Affordable Care Act ,
Appropriations Bill ,
Automotive Industry ,
Big Data ,
Bioengineering ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
CFIUS ,
Covered Transactions ,
Critical Infrastructure Sectors ,
Cross-Border Transactions ,
Cyber Attacks ,
Cybersecurity ,
Decriminalization of Marijuana ,
Final Rules ,
FIRRMA ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Food Supply ,
Foreign Investment ,
Health Insurance ,
Healthcare Reform ,
Intellectual Property Protection ,
Legislative Agendas ,
Marijuana ,
Medicaid ,
Medical Foods ,
National Security ,
Oil & Gas ,
Pipelines ,
Plant Based Products ,
Recreational Use ,
Retail Market ,
Sports Betting ,
Sports Gambling ,
Standard Essential Patents ,
Taxation ,
USDA
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
FDA on September 23 issued a Drug Supply Chain Security Act (DSCSA)– related compliance policy stating it will not take enforcement action against wholesalers that do not have systems in place to verify product identifiers of...more
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
The US Supreme Court held on May 20 that a judge, not a jury, must decide the question of whether federal law prohibited drug manufacturers from adding warnings to the drug label that would satisfy state law. To succeed on a...more
6/3/2019
/ Agency Disapproval ,
Clear Evidence Standard ,
Failure To Warn ,
FDA Approval ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Jury Trial ,
Manufacturers ,
Merck Sharp & Dohme Corp. v. Albrecht ,
Preemption ,
Prescription Drugs ,
Question of Fact ,
Question of Law ,
Remand ,
SCOTUS ,
State Law Claims ,
Vacated ,
Warning Labels
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
California Governor Jerry Brown is expected to sign into law two bills concerning cosmetic products sold in California. The first bill, SB 1249, would ban animal testing from all cosmetic products sold in California. The...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
The federal bill was signed into law on May 30 by the president, and will present new opportunities and challenges to clinical trial sponsors and healthcare entities....more
The US Food and Drug Administration’s new requirements for sponsors to follow Good Clinical Practices (GCPs) for ex-US device clinical trials will affect device development strategies, including where to conduct such trials....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
Public interest groups challenge FDA’s “Generally Recognized as Safe” Rule as failing to ensure food ingredients are safe for consumers....more
The draft language reauthorizes FDA’s authority to assess user fees and proposes fee restructuring and increases.
On April 14, the health committees for both the US Senate and the US House of Representatives released a...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
Court holds that FDA guidance cannot require preapproval for label modifications to existing tobacco products, but can require preapproval for quantity modifications....more