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
Mar
25
2020
Top 10 Questions Asked By Medical Group Clients In Response To COVID-19 Sheppard, Mullin, Richter & Hampton LLP
Jun
19
2020
Not Today Corona: EEOC Prohibits Testing Employees for Antibodies Sheppard, Mullin, Richter & Hampton LLP
Jul
2
2020
High Risk of Second Requests in the Cannabis Industry Sheppard, Mullin, Richter & Hampton LLP
Aug
10
2020
“Buy American” in the Twilight Zone: Executive Order Strengthening the U.S. Public Health Industrial Base Sheppard, Mullin, Richter & Hampton LLP
Apr
3
2024
FTC’s Campaign Against Improper Orange Book Listings Continues with Amicus Brief in Teva’s Challenge of Amneal Asthma Inhaler ANDA Sheppard, Mullin, Richter & Hampton LLP
May
7
2024
Cannabis Operator Challenges California State Statute and Regulations Requiring Labor Peace Agreements Sheppard, Mullin, Richter & Hampton LLP
Jan
27
2021
CMS to the Rescue for MA and Part D Plans – Rate Announcement Includes Significant Increase in Plan Payments for 2022 Sheppard, Mullin, Richter & Hampton LLP
Mar
26
2021
Online Cannabis Marketplace Businessmen Convicted of Conspiracy to Commit Bank Fraud Sheppard, Mullin, Richter & Hampton LLP
Aug
17
2017
Scrambling After an Egg Crisis – EU Safety Guidance for Online Product Sales Sheppard, Mullin, Richter & Hampton LLP
Jan
13
2011
New Defense Authorization Act Imposes Buy American Act Mandate for Photovoltaics Sheppard, Mullin, Richter & Hampton LLP
Nov
16
2021
Are Flavor Cases Fizzling? Two More Courts Grant Motions to Dismiss Sheppard, Mullin, Richter & Hampton LLP
Nov
2
2018
OIG Report on Topical Compounded Drug Prescribing, Marketing and Billing Practices Signals Heightened Administrative and Enforcement Scrutiny Sheppard, Mullin, Richter & Hampton LLP
Mar
30
2022
Movement On CMRE Act and MORE Act On Capitol Hill Sheppard, Mullin, Richter & Hampton LLP
Apr
20
2022
FDA Issues Untitled Letter to Bausch Health Companies for Misleading Statements Relating to DUOBRII™ Sheppard, Mullin, Richter & Hampton LLP
Jun
29
2022
Time Is Not Always Money: Ninth Circuit Holds That Pre-Employment Drug Testing Is Not Compensable Under California Law Sheppard, Mullin, Richter & Hampton LLP
May
8
2019
AAFCO Issues Updated Guidelines Regarding Hemp in Animal Food Sheppard, Mullin, Richter & Hampton LLP
Aug
8
2022
FDA Delays Enforcement of UDI Reporting Requirements for Consumer Health Products Sheppard, Mullin, Richter & Hampton LLP
May
20
2019
Location Matters – Manufacturing Insights from FDA’s Annual Report on Drug Quality Sheppard, Mullin, Richter & Hampton LLP
Aug
30
2022
Charging for Investigational Drugs Under an IND Questions and Answers, Draft Guidance for Industry, August 2022 Sheppard, Mullin, Richter & Hampton LLP
Dec
16
2014
Sandoz and Celltrion Decline the Invitation to Dance: Biosimilars Challenge the Applicability of the BPCIA’s Exchange Provisions Before Bringing Suit Sheppard, Mullin, Richter & Hampton LLP
Feb
19
2015
Go For De Novo: FDA’s Revised Approach to Medical Device Accessories Sheppard, Mullin, Richter & Hampton LLP
Sep
30
2019
CBD Industry Beware: The False Labeling Class Action Has Arrived Sheppard, Mullin, Richter & Hampton LLP
Oct
3
2019
Third Circuit Holds that SLUSA Does Not Preclude Class Action Opt-Outs from Pursuing Individual Actions Sheppard, Mullin, Richter & Hampton LLP
Oct
30
2019
BREAKING NEWS: USDA Releases Interim Final Hemp Rule Sheppard, Mullin, Richter & Hampton LLP
Jun
14
2023
FDA Issues Proposed Rule for Standardized and Accessible Patient Medication Information Sheppard, Mullin, Richter & Hampton LLP
Mar
5
2020
How FDA is Reacting to the Coronavirus, and 2020 Regulatory Priorities Sheppard, Mullin, Richter & Hampton LLP
Mar
11
2020
FDA Commissioner Signals Enforcement Policy, Advancement of Research for CBD Products Sheppard, Mullin, Richter & Hampton LLP
Sep
7
2023
Context is Key: FDA Sends a Strong Message About Efficacy Claims Sheppard, Mullin, Richter & Hampton LLP
 

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