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 ascending
Feb
17
2016
FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness McDermott Will & Emery
Sep
8
2023
FDA Issues Final Guidance on Informed Consent in Clinical Investigations McDermott Will & Emery
May
23
2016
FDA to Issue Revised Guidance on Nutrition and Supplement Facts and Serving Size Regulations McDermott Will & Emery
Oct
16
2023
The Fine Print: Avoiding IP Pitfalls in Unlicensed Fonts McDermott Will & Emery
Jul
1
2016
No Approval for Generic Product for Treatment of Rosacea McDermott Will & Emery
Aug
3
2016
FDA Finalizes Guidance on Low Risk General Wellness Devices McDermott Will & Emery
Aug
10
2016
FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices McDermott Will & Emery
Aug
16
2016
HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims McDermott Will & Emery
Dec
22
2023
Medicare Provider and Supplier Enrollment Requirements: Program Integrity Changes for 2024 McDermott Will & Emery
Nov
22
2016
Expansion of Liability in Product Labeling Cases McDermott Will & Emery
Jan
27
2017
FDA Issues Draft Guidance on Communications That Are Consistent with FDA-Required Labeling McDermott Will & Emery
Apr
4
2024
Take the Beer Goggles Off: Ambiguity Prevents Summary Judgment McDermott Will & Emery
Mar
7
2017
Proposed Regulation in Texas on Name and Address Labeling for Malt Beverages McDermott Will & Emery
Oct
15
2020
Federal Circuit Restores Induced Infringement Verdict Against Teva McDermott Will & Emery
Oct
29
2020
Cookie Trade Dress Infringement Case Crumbles in Face of Functionality Challenge McDermott Will & Emery
Aug
29
2017
Counsel’s Actions Support Inference of Intent to Deceive PTO: Regeneron Pharmaceuticals v. Merus N.V. McDermott Will & Emery
Nov
25
2017
Claim to Gel Formulation Not Obvious Over Prior Art Liquid Formulation McDermott Will & Emery
Oct
3
2012
Prometheus Redux: Patentability of Isolated DNA Sequences Are Patentable Subject Matter McDermott Will & Emery
Feb
7
2018
CMS Encourages Innovation in MA, Asks Part D Plans to Combat Opioid Overuse, and Fine-Tunes Payments McDermott Will & Emery
Feb
16
2018
A Declaration without a Response: Senators Urge DEA to Enact Regulations on Opioid-Based Addiction Treatments Using Telemedicine McDermott Will & Emery
Jan
28
2013
Los Angeles Kicks Off Its Feed-in Tariff Program McDermott Will & Emery
Jul
24
2013
Illinois Set to Regulate Shale Oil and Gas McDermott Will & Emery
Jul
31
2013
Massachusetts Department of Public Utilities (DPU) Adopts Procedures for Relaxing Eligibility for Net Metering Renewable Energy Facilities McDermott Will & Emery
Sep
5
2013
Third Circuit Prevention of Significant Deterioration (PSD) Decision is a Loss for EPA, But Also Contains Warnings for Power Plant Owners McDermott Will & Emery
Jul
23
2018
TTB Issues Guidance on Transfers of Beer between Breweries of Different Ownership McDermott Will & Emery
Nov
5
2021
CMS Issues COVID-19 Vaccination Interim Final Rule for Healthcare Facilities McDermott Will & Emery
Aug
17
2018
DEA Proposes Reduction in US Opioid Manufacturing Quotes McDermott Will & Emery
Oct
12
2018
TTB Publishes Updated Guidelines for Formula Approvals for Domestic Producers and Importers McDermott Will & Emery
 

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