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
Jan
18
2017
FDA Issues Final Guidance on Benefit-Risk for Investigational Device Exemptions Barnes & Thornburg LLP
Jul
24
2017
FDA Publishes Final List of Class II Devices to be Exempted from 510(K) Process Barnes & Thornburg LLP
Sep
18
2017
FDA Reauthorization Act Requires Changes to Medical Device Inspections Alert Barnes & Thornburg LLP
Feb
17
2012
FDA Issues Long-Awaited Draft Guidance Documents on Biosimilars Barnes & Thornburg LLP
Mar
16
2018
Michigan DEQ Says Industrial Pretreatment Programs Must Address Emerging Containment PFAS Barnes & Thornburg LLP
Nov
1
2013
The Scarlet Letter: Asbestos Litigation for the New or Low-Profile Defendant Barnes & Thornburg LLP
Apr
26
2022
What’s Brewing at Starbucks? Labor Law Litigation Over Employee Terminations Barnes & Thornburg LLP
Oct
6
2015
Summary of Management Standards for Hazardous Waste Pharmaceuticals Proposed Rule Barnes & Thornburg LLP
Apr
29
2020
U.S. Supreme Court Holds Federal Government Accountable for ACA Promises Barnes & Thornburg LLP
Oct
13
2016
Effective Immediately: FDA Adds More Food Categories to Registration of Food Facilities Barnes & Thornburg LLP
May
26
2017
Planting the Seed: Three Takeaways from Ag & Food Conference Barnes & Thornburg LLP
Jan
3
2018
FDA Issues Amended Final Guidance on Medical Device Accessories Barnes & Thornburg LLP
Jan
18
2018
Settlement in Flu Shot Case Provides Lessons for Mandatory Vaccine Programs Barnes & Thornburg LLP
Mar
23
2018
Medical Marijuana is Coming to Ohio– What Employers Need to Know Barnes & Thornburg LLP
Aug
7
2013
Challenges of EPA Rules Requiring States to Address Greenhouse Gases in State Implementation Program (SIP) Plans Dismissed by D.C. Circuit Barnes & Thornburg LLP
Nov
1
2013
Rethinking Preemption in the Defense of Aerosol Cans (And Other Department of Transportation (DOT)-Regulated Containers) Barnes & Thornburg LLP
Nov
14
2013
U.S. Environmental Protection Agency (EPA) Civil Penalties Increase, Just in Time for the Holidays! Barnes & Thornburg LLP
Apr
2
2014
Ohio Senate Votes to Pass Leadership in Energy and Environmental Design (LEED) Certification Ban Barnes & Thornburg LLP
Aug
7
2014
FDA Releases Final Guidance on Expedited Center for Devices and Radiological Health (CDRH) Appeals Barnes & Thornburg LLP
Aug
25
2014
FDA Issues Draft Guidance on De Novo Process Barnes & Thornburg LLP
Mar
15
2022
FDA Proposes To Harmonize Medical Device Quality System Regulations With ISO 13485 Barnes & Thornburg LLP
Feb
2
2015
FDA Issues Draft Guidance on Medical Device Accessories Barnes & Thornburg LLP
May
27
2015
FDA Issues Draft Guidance on Mandatory Food Recalls Under the Food Safety Modernization Act Barnes & Thornburg LLP
Dec
14
2015
Nip it in Bud: Employer Considerations Following Debut of Medical Marijuana in Illinois Barnes & Thornburg LLP
Aug
24
2016
FDA Revises 2011 Draft Guidance on New Dietary Ingredients for Supplements Barnes & Thornburg LLP
Aug
29
2016
FDA Issues Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food Barnes & Thornburg LLP
Mar
15
2017
FDA Published List of Class II Devices to be Exempt From 510(K) Process Barnes & Thornburg LLP
Mar
9
2013
Environmental Protection Agency (EPA) Proposes to Eliminate Startup, Shutdown, and Malfunction Air Emission Exemptions in 36 States Barnes & Thornburg LLP
 

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