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
Feb
27
2015
FDA Proposal to Regulate Laboratory Developed Tests Raises Legal Liability Questions for Labs Covington & Burling LLP
Jul
9
2015
FDA to Focus on “Complementary” Diagnostics in Addition to Companion Diagnostics Covington & Burling LLP
Apr
20
2016
Non-Trade Agreements Act-Compliant Covered Drugs Must be Offered to VA in Coming Weeks Covington & Burling LLP
Oct
21
2016
French Supreme Court upholds Sanofi’s generic denigration fine Covington & Burling LLP
Jan
24
2017
Italian Council of State Improves Access to Investigational Medicines Covington & Burling LLP
Feb
8
2018
Hoffmann-La Roche – Some Broader Implications Covington & Burling LLP
Jul
24
2014
China Releases New Notification Procedures for Class I Medical Devices Covington & Burling LLP
Oct
28
2014
Texas Federal Jury Sides with J&J’s DePuy In First Pinnacle Hip Implant Trial Covington & Burling LLP
Dec
5
2014
EU Commission Publishes Fifth Report On Patent Settlements In the Pharmaceutical Sector Covington & Burling LLP
Jan
20
2015
Myriad’s Fight Continues: Federal Circuit Finds Composition and Method Claims Ineligible Covington & Burling LLP
Feb
10
2015
China Struggles With Food Safety Covington & Burling LLP
Apr
2
2015
Moving to the Cloud: Some Key Considerations for Healthcare Entities Covington & Burling LLP
Apr
14
2015
European Court to Clarify Responsibilities and Liability for Medical Devices Covington & Burling LLP
May
6
2015
FDA Issues Draft Guidance on Determining when Data from Foreign Clinical Studies Can Support Device Submissions Covington & Burling LLP
Sep
16
2015
Proposed Rule Would Amend Federal “Common Rule” Requirements Covington & Burling LLP
Sep
25
2015
Report Outlines Plan for Precision Medicine Database Covington & Burling LLP
Nov
29
2015
Food Labeling: FDA Issues Final Guidance on Voluntary GE Claims on Food Products, One Week After Requesting Information and Comments on “Natural” Claims Covington & Burling LLP
Dec
21
2015
China FDA Restructures Medical Device Adverse Event Regulations Covington & Burling LLP
Apr
20
2016
HRSA Seeks Second Round of Comments on 340B Penny Pricing, New Drug Estimates, and Civil Monetary Penalties Covington & Burling LLP
Aug
4
2016
FDA FY 2017 Medical Device User Fees Announced Covington & Burling LLP
Sep
2
2016
FDA to hold Public Hearing on Communicating Information about Off-Label Conditions of Use Covington & Burling LLP
Sep
30
2016
Industry Guidance on Unapproved or Off-Label Information Provides Insight Into Issues Under FDA Review Covington & Burling LLP
Apr
4
2017
House Discussion Draft Released on Regulatory Approach for In Vitro Clinical Tests Covington & Burling LLP
Nov
15
2017
Pharmaceutical Digital Health Innovators Take Note: FDA Public Hearing on an Innovative Approach to Devices Referencing Drugs Covington & Burling LLP
Sep
21
2018
The Week Ahead in the European Parliament – September 21, 2018 Covington & Burling LLP
Aug
8
2014
FDA Announces Intent to Issue Draft Guidance Documents Describing Regulatory Framework for Laboratory Developed Tests Covington & Burling LLP
Sep
9
2014
Decision Requiring Commercial-Item Suppliers to Comply with Non-Standard Terms under the Federal Acquisition Regulation (FAR) Is Stayed Pending Appeal at Federal Circuit Covington & Burling LLP
Oct
29
2014
Government Looking to Existing Procurement Vehicles to Stem Ebola Threat Covington & Burling LLP
 

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