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
Aug
15
2016
FDA Finalizes Guidance on General Wellness Devices, Will Not Regulate Barnes & Thornburg LLP
Feb
20
2024
Federal Judge Grants HHS-OIG Victory For Interpretation Of Anti-Kickback Statute In Prior Advisory Opinion Barnes & Thornburg LLP
Jun
30
2020
Ohio Appellate Court Rules That Insurer Must Defend Party Involved In Opioid MDL Barnes & Thornburg LLP
Jun
29
2017
Content of Doctors’ Notes May Help Plaintiffs Establish Evidence of Disability Discrimination Barnes & Thornburg LLP
Jan
23
2018
Food, Drug, and Device Law Alert - FDA Proposes Defining "Significant Decision" in Safety and Innovation Act Barnes & Thornburg LLP
Mar
31
2014
EPA (Environmental Protection Agency) Proposes Rulemaking: Revising the Regulatory Definition of "Waters of the United States" Barnes & Thornburg LLP
May
2
2014
Promoting Renewable Energy Redevelopment of Brownfields - Formerly Contaminated Properties, Landfills and Mine Sites Barnes & Thornburg LLP
Apr
16
2015
FDA Proposes to Amend Regulations on Food Facility Registration Barnes & Thornburg LLP
May
11
2015
Amarin Pharma Preemptively Sues FDA over First Amendment Rights Barnes & Thornburg LLP
Nov
19
2019
Case Summaries Barnes & Thornburg LLP
Jun
30
2023
The O-1 Extraordinary Ability Visa: An Attractive Alternative to the H-1B Barnes & Thornburg LLP
Oct
9
2023
Notable New California Employment Bills Signed Into Law – Part 1 Barnes & Thornburg LLP
Mar
18
2020
FDA Issues Final Guidance On Third-Party Review Of 510(K) Applications Barnes & Thornburg LLP
Jul
18
2016
FDA Amends Final Rule on Registration of Food Facilities Barnes & Thornburg LLP
Jan
3
2017
FDA Finalizes Guidance on Benefit-Risk Factors to Consider Regarding Medical Device Availability, Compliance, and Enforcement Barnes & Thornburg LLP
Apr
19
2017
Ohio to Dedicate $20 Million to Opioid Research Barnes & Thornburg LLP
Apr
16
2013
Renewable Energy Alert - IRS Releases 2013 Annual Inflation Factor and Reference Prices For Section 45 Production Tax Credits Barnes & Thornburg LLP
Aug
3
2013
Seventh Circuit Deals Major Blow to the Environmental Protection Agency's (EPA) New Source Review Enforcement Barnes & Thornburg LLP
Nov
19
2013
Pipeline and Hazardous Materials Safety Administration (PHMSA) Rules Increase Maximum Penalties and Revise Investigation and Hearing Procedures Barnes & Thornburg LLP
Oct
5
2018
FDA Issues Final Guidance on Medical Device Benefit and Risk Analysis for 510(K)S Barnes & Thornburg LLP
Dec
5
2018
Michigan Employer Action Steps for Recreational Marijuana Barnes & Thornburg LLP
Jun
13
2014
Supreme Court Holds Competitors May Bring False, Misleading Product Descriptions Claims on Food, Beverage Labels Barnes & Thornburg LLP
May
11
2015
FDA Releases Draft Guidance on Using Clinical Data from Studies Conducted Outside the United States to Support Approval of Medical Devices Barnes & Thornburg LLP
Jun
9
2015
FDA Issues Draft Guidance on Voluntary Qualified Importer Program Under the Food Safety Modernization Act Barnes & Thornburg LLP
Mar
7
2023
HHS-OIG Foregoes Sanctions On Drug Manufacturer For Providing Free Drugs To Patients Waiting For Insurance Authorization Barnes & Thornburg LLP
Nov
17
2015
FDA Publishes Final Rule on Foreign Supplier Verification Program Barnes & Thornburg LLP
Mar
2
2020
FDA Launches Limited Pilot Program For Interactive 510(K) Application Barnes & Thornburg LLP
Jun
14
2016
Reminder: Vermont GMO Labeling Law (Vermont Act 120) Goes into Effect on July 1 Barnes & Thornburg LLP
 

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