Biotech, Food & Drug

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In today’s hyper-aware environment, concerns about food and drug safety are paramount for both companies and consumers.  The Food and Drug Administration (FDA) and the US Department of Agriculture (USDA) regulates the areas of biotech, food, and drug law. Additionally, laws including the 21st Century Cures Act, and cGMP (Current Good Manufacturing Processes), regulate industry standards/norms in food, cosmetics, and other industry-sectors. Visitors to the National Law Review will find the latest analysis of news, legislation, and upcoming cases/litigation as it relates to this area of law.

With researchers searching for new energy solutions and other developments in biotech, visitors to the NLR will have the opportunity to read content surrounding biosimilars, natural fuel production, medical devices, biotechnology, nanotechnology and materials, and the pharmaceuticals industry. Additionally, content relating to food and drug laws, limits on chemical use in cosmetic products, and other general health/safety topics are covered by the National Law Review and are updated regularly. Additionally, food safety and imports to the United States are also discussed as they become relevant. 

In addition to general health, science, and food/drug, the industry is also closely related to many of the issues related to intellectual property law. New applications for patents, intellectual property, licensing laws, and other areas which are governed by the PTAB court, often crossover into the industry.

New developments in legislation, including the legalization of recreational marijuana has created a new area ripe for legal analysis.  Regulations on how recreational marijuana can be advertised and marketed, distributed and the kind of insurance coverage necessary for dispensaries.  Additionally, employer drug-testing and marijuana statutes have been a hot area of litigation covered by the National Law Review.  

General practices in marketing standards, compliance of federal and state laws/legislation, licensing collaborations, and news related to bringing new products to the market, in the US and abroad, are among the areas visitors to NLR will read about daily. Drug pricing, changes in production standards, regulatory compliance, food safety and handling, drug laws (legalization of marijuana, both recreational and medicinal in the workplace), and labeling and nutritional requirements, are among the many topics covered by the National Law Review daily.

Visitors will always find the latest, up-to-date, most comprehensive coverage on the site. And, news and stories which affect the US, companies which are regulated in the industry, and multinational/international companies, are detailed regularly for NLR readers.

National Law Review Cannabis TwitterFor hourly updates on the latest news about biotech, food & drug, and cannabis laws, regulations, and legislation, be sure to follow our Cannabis X (formerly Twitter) feed, and sign up for complimentary e-news bulletins.

Recent Biotechnology, Food & Drug Administration FDA News

Title
Publication Date Organization Sort descending
Dec
4
2020
California’s Parallel State Law Duty to Report Adverse Events to U.S. Food and Drug Administration Cannot Be Reconciled with Legal Precedent Faegre Drinker
Dec
21
2017
FDA Issues New Draft Guidance on “Least Burdensome” Principles for Medical Devices Faegre Drinker
Jan
3
2018
Oncology Services Provider Reaches $2.3 Million Settlement with HHS for Data Breach Faegre Drinker
Mar
31
2016
Coalition For Affordable Drugs VIII v. Trustees Of University Of Pennsylvania: Patent Not Entitled to Filing Date of Provisional Because Claims Not Supported By Provisional IPR2015-01835 Faegre Drinker
Mar
17
2020
Congress Considers Expansive Coronavirus Package, Including Paid Leave and Free Testing Faegre Drinker
Apr
3
2020
FDA Funding Opportunity Announcement: “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional” Faegre Drinker
Apr
14
2020
Ingredient Lists Still Matter: California Federal Court Dismisses White Baking Chips Lawsuit Faegre Drinker
May
13
2020
FDA Releases Guidance Requiring Notification of Certain Medical Device Shortages Related to COVID-19 Testing and Treatment Faegre Drinker
May
2
2018
Continued Special Privacy Treatment for Substance Use Disorder Information Faegre Drinker
Jul
25
2014
The FDA’s Informed Consent Draft Guidance: Insights and Challenges for IRBs, Clinical Investigators and Sponsors Faegre Drinker
Nov
11
2014
BioDelivery Sciences International, Inc. v. MonoSol Rx, LLC: Decision Denying Institution IPR2014-00794 Faegre Drinker
Jun
30
2015
Teva Pharm v. ViiV Healthcare Co: Denying Joinder Where Agreement to File Consolidated Papers Was Not Obtained IPR2015-00550 Faegre Drinker
Jul
28
2015
Amneal Pharm v. Endo Pharmaceuticals: Final Written Decision Finding Claim Limitation Not Inherently Disclosed IPR2014-00360 Faegre Drinker
Dec
21
2019
Illinois Amends Recreational Marijuana Statute to Clarify Employers’ Rights Faegre Drinker
Jun
24
2020
Citizen’s Petition Filed for FDA Pathway to Legally Market Supplements With CBD Faegre Drinker
Nov
13
2020
Preemption of Structure/Function Claims Faegre Drinker
Jan
15
2021
COVID-19 Weekly Newsletter: Biden Announces Ambitious Vaccination Plan Faegre Drinker
Jan
27
2021
SEC Enforcement Victory in its Efforts to Police Cannabis Industry Investments Faegre Drinker
Jan
3
2018
Recent OCR Action Provides HIPAA Guidance Related to Opioid Crisis and Privacy Rule in Research Faegre Drinker
Aug
18
2012
Technology: Medical device companies may see increased regulation Faegre Drinker
Mar
20
2014
$1.2 Billion Medicaid Fraud Penalty Award Reversed and Claim Dismissed in Arkansas Appeal Faegre Drinker
Sep
10
2014
Ariosa Diagnostics v. Isis Innovation Limited: Final Written Decision (Motion to Amend) IPR2012-00022 Faegre Drinker
Feb
10
2015
Clinical Trial Data: Shared Resource or Private Property? Faegre Drinker
Apr
21
2015
Can One Bad Apple Spoil the Bunch? re: Arctic Apples and Insurance Claims Faegre Drinker
Aug
31
2015
Getting Serious about Palcohol: Powdered Alcohol Faegre Drinker
May
18
2020
Vermont Federal Court Orders Ben & Jerry’s “Happy Cows” Lawsuit Out to Pasture Faegre Drinker
Dec
12
2020
COVID-19 Weekly Newsletter: FDA Committee Recommends Vaccine Approval Faegre Drinker
Feb
4
2021
“Vanilla” Milk Claims Continue to Sour as Southern District of New York Dismisses Putative Class Action Complaint Faegre Drinker
 

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