FDA issued an updated Q&A guidance in September 2021, Microbiological Considerations for Antimicrobial Agents Used in Food Applications: Guidance for Industry (Antimicrobial Agents Guidance), which replaces a guidance...more
FDA recently entered into domestic mutual reliance (DMR) agreements with the states of California, Florida, Utah, and Wisconsin to help ensure the safety of domestic food production and distribution systems. FDA’s goal is to...more
The US Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published a final rule on December 21, 2018, implementing the National Bioengineered Food Disclosure Standard (NBFDS). Beginning on January 1,...more
Congress on August 3 introduced the Food Labeling Modernization Act of 2021 (H.R. 4917 or 2021 Bill), a bill that proposes to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to improve requirements related to summary...more
A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse...more
8/16/2021
/ AMG Capital Management LLC v FTC ,
Antitrust Violations ,
Biosimilars ,
Competition ,
Exclusive Licenses ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
FTC Act ,
Generic Drugs ,
Hatch-Waxman ,
Manufacturers ,
Noerr-Pennington Doctrine ,
Pharmaceutical Industry ,
Reverse Payment Settlement Agreements
The Federal Trade Commission (FTC) recently issued a final rule that marks a major shift in the regulatory landscape for labeling that has already begun to impact other regulatory bodies—namely, the US Department of...more
On December 14, 2020, the US Food and Drug Administration (FDA) approved GalSafe pigs, which are genetically modified (GM) for use in food production and medical products. At the time, the agency noted in its Consumer Q&A...more
6/23/2021
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biotechnology ,
Federal Meat Inspection Act (FMIA) ,
Food and Drug Administration (FDA) ,
Food Safety ,
Genetically Engineered Animals ,
Memorandum of Understanding ,
Poultry Products Inspection Act (PPIA). ,
Proposed Rules ,
Regulatory Oversight ,
USDA
US Senators Ron Wyden (D-Ore.), Rand Paul (R-Ky.), and Jeff Merkley (D-Ore.) introduced legislation on May 21 to ensure hemp-derived cannabidiol (CBD) is regulated by the US Food and Drug Administration (FDA) like other...more
6/2/2021
/ Beverage Manufacturers ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Dietary Supplements ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Health and Safety ,
Legislative Agendas ,
Marijuana ,
Plant Based Products ,
Regulatory Agenda ,
Regulatory Oversight
The month of May was buzzing with good news for the edible insect industry, but this emerging food trend still faces regulatory uncertainty in the United States....more
To enhance its food traceability objective through the use of technology that strengthens the food safety system, the US Food and Drug Administration (FDA) unveiled, on May 19, its latest initiative through which it hopes to...more
A US Court of Appeals for the Ninth Circuit panel recently affirmed a decision by the US Food and Drug Administration (FDA) approving soy leghemoglobin (also known as “heme”), a soy protein ...more
US President Joseph Biden signed into law the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) in April, establishing sesame as the ninth major food allergen under the Federal Food ...more
5/11/2021
/ Biden Administration ,
Disclosure Requirements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food Allergies ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
New Legislation ,
Public Health ,
Retail Market
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on...more
As the United States races to deliver safe and effective coronavirus (COVID-19) vaccines under the Biden administration, employers, healthcare providers, and many others are assessing what it means for their industries and...more
2/1/2021
/ Americans with Disabilities Act (ADA) ,
Civil Rights Act ,
Coronavirus/COVID-19 ,
Employer Liability Issues ,
Employment Policies ,
Equal Employment Opportunity Commission (EEOC) ,
Infectious Diseases ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Reasonable Accommodation ,
Title VII ,
Vaccinations ,
Wage and Hour ,
Workplace Safety
The Food and Drug Administration (FDA) issued a press release on January 26 announcing a countrywide import alert on all alcohol-based hand sanitizers manufactured in Mexico due to their potential methanol content. The press...more
1/29/2021
/ Coronavirus/COVID-19 ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Imports ,
Infectious Diseases ,
Life Sciences ,
Mexico ,
Sanitation ,
Toxic Chemicals ,
Toxic Exposure
Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations....more
1/27/2021
/ Biden Administration ,
Critical Infrastructure Sectors ,
Enforcement Actions ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Innovation ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Supply Chain
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act....more
12/9/2020
/ Civil Liability ,
Coronavirus/COVID-19 ,
Countermeasures ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Immunity ,
Infectious Diseases ,
Medical Malpractice ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Telehealth ,
Vaccinations
As the world awaits a successful COVID-19 vaccine, employers are beginning to consider the implications a new vaccine will have on their workplaces. Although much remains speculative, employers can look to the regulation of...more
11/10/2020
/ Americans with Disabilities Act (ADA) ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Employer Liability Issues ,
Equal Employment Opportunity Commission (EEOC) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
OSHA ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Title VII ,
Trump Administration ,
Vaccinations ,
Workers' Compensation Claim
The coronavirus (COVID-19) pandemic continues to impact the biopharmaceutical industry. In a recent guidance, Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (the...more
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it...more
Welcome to the August 2020 issue of our Life Sciences International Review. This issue covers new developments within Asia, Europe, and the United States in intellectual property, regulatory, pricing, and international trade,...more
8/24/2020
/ Asia ,
Coronavirus/COVID-19 ,
Digital Health ,
EU ,
Food and Drug Administration (FDA) ,
Force Majeure Clause ,
Foreign Direct Investment ,
Fraud ,
Life Sciences ,
Medical Devices ,
Over The Counter Drugs (OTC) ,
Patent Terms ,
Pharmaceutical Industry ,
Prescription Drugs
As the coronavirus (COVID-19) pandemic resurges, PREP Act liability immunity continues to be critical for manufacturers and users of COVID-19 medical products. ...more
The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system....more
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight,...more
7/9/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Immunity ,
Product Defects ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Risk Mitigation ,
Suppliers ,
Supply Chain ,
Telehealth
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more
7/1/2020
/ Biologics ,
Biosimilars ,
CGMP ,
Clinical Trials ,
Coronavirus/COVID-19 ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Requirements ,
Research and Development