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
Oct
6
2022
BREAKING NEWS: Biden to Pardon Federal Marijuana Possession Convictions Sheppard, Mullin, Richter & Hampton LLP
Dec
2
2020
Eleventh Hour Rulemaking: HHS Eliminates Safe Harbor Protections for PBM Drug Rebates; and Creates Two New Safe Harbors for Point-of-Service Discounts and PBM Fixed-Fee Arrangements Sheppard, Mullin, Richter & Hampton LLP
Jan
29
2021
NLRB’s Division of Advice Determines Certain Workers in the Cannabis Industry Are Exempt From Federal Labor Law Sheppard, Mullin, Richter & Hampton LLP
Dec
9
2010
Adjusting the Inequitable Conduct Doctrine: Federal Circuit Hears Oral Arguments En Banc in Therasense Sheppard, Mullin, Richter & Hampton LLP
Jul
14
2023
FDA Releases Final Guidance on Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements Sheppard, Mullin, Richter & Hampton LLP
Jul
31
2023
UCB, Inc. v. Actavis Laboratories UT, Inc. No. 2021-1924, (Fed. Cir. Apr. 12, 2023) Sheppard, Mullin, Richter & Hampton LLP
Sep
1
2023
Reclassifying Cannabis as a Schedule III Substance – Will the DEA Agree? Sheppard, Mullin, Richter & Hampton LLP
Jul
11
2013
Farming Solar Rays: County Decision to Approve Industrial-Scale Solar on Williamson Act Lands OK'd Sheppard, Mullin, Richter & Hampton LLP
Oct
7
2013
California Passes Landmark Green Chemical Laws Sheppard, Mullin, Richter & Hampton LLP
Sep
20
2018
Federal Antitrust Regulators Approve Cigna’s Proposed Acquisition of Express Scripts Sheppard, Mullin, Richter & Hampton LLP
May
31
2014
Developer-Prepared Cost Comparisons Can Show Economic Infeasibility Under CEQA - California Environmental Quality Act Sheppard, Mullin, Richter & Hampton LLP
Nov
3
2014
Agricultural Cooperative Antitrust Litigation Continues to Mushroom Sheppard, Mullin, Richter & Hampton LLP
Jan
5
2015
New FDA Draft Guidance on REMS and Bioequivalence Studies: Does New Procedure Secure ANDA Applicants The Right to Obtain Samples? Sheppard, Mullin, Richter & Hampton LLP
Sep
22
2021
Elijah E. Cummins Lower Drug Costs Now Act: The Long and Winding Road to Drug Pricing Reform Sheppard, Mullin, Richter & Hampton LLP
Feb
12
2020
Federal Circuit Revolutionizes Country of Origin Analysis for Pharmaceuticals Sheppard, Mullin, Richter & Hampton LLP
Nov
22
2021
FDA Joins Other Regulators in Focus on AI and Machine Learning Sheppard, Mullin, Richter & Hampton LLP
Mar
31
2020
Personal Protective Equipment & Ventilators: How FDA Is Increasing Supply for the US Healthcare System Sheppard, Mullin, Richter & Hampton LLP
Mar
24
2022
HHS OIG Signs Off on Substance Use Recovery Incentive Program Sheppard, Mullin, Richter & Hampton LLP
Jun
23
2020
FDA Issue Guidance on Manufacturing Drugs, APIs during COVID-19 Sheppard, Mullin, Richter & Hampton LLP
Sep
15
2022
California Expands FEHA to Include Off The Job Cannabis Use Sheppard, Mullin, Richter & Hampton LLP
Oct
31
2022
CMS Heightens Oversight of TPMO Marketing Programs, Restricts TV Advertisements Sheppard, Mullin, Richter & Hampton LLP
Dec
11
2020
It’s Not Pop Secret, Ninth Circuit Affirms that Plaintiff Didn’t Have a Leg to Stand On Sheppard, Mullin, Richter & Hampton LLP
Dec
6
2022
Don’t Let Drugs Bring You Down: The Importance of an Effective Drug Diversion Program Sheppard, Mullin, Richter & Hampton LLP
Jun
6
2023
FDA Clarifies Approach to Pediatric Drug Development Sheppard, Mullin, Richter & Hampton LLP
Mar
29
2011
A MATRIXX Revolution, Part II: Supreme Court affirms Ninth Circuit's holding that Life Science Companies Cannot Rely On a Statistical Significance Standard When Deciding Whether Adverse Event Reports are Material for the Purpose of Securities Disclosures Sheppard, Mullin, Richter & Hampton LLP
Dec
20
2017
California Court of Appeal Affirms Judgment Finding No Duty to Defend Drug Manufacturer in Lawsuits Alleging Increased Opioid Usage Sheppard, Mullin, Richter & Hampton LLP
Dec
10
2013
New “Potentially Feasible” Alternative Does Not Trigger Draft Environmental Impact Report (EIR) Recirculation Unless Considered “Significant New Information”; No Findings Needed to Reject Alternative As Infeasible Sheppard, Mullin, Richter & Hampton LLP
Mar
21
2019
Federal Circuit Weighs in on Patent Subject-Matter Eligibility of Dietary Supplements Sheppard, Mullin, Richter & Hampton LLP
 

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