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
Jul
11
2013
Farming Solar Rays: County Decision to Approve Industrial-Scale Solar on Williamson Act Lands OK'd Sheppard, Mullin, Richter & Hampton LLP
Sep
29
2021
Impact of NYC’s New Delivery Service Data Sharing Requirement 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
Apr
18
2022
China Proposed Draft Implementing Rules for Human Genetic Resources Management Sheppard, Mullin, Richter & Hampton LLP
May
19
2022
FDA White Paper Signals Shift to Performance-Based Reviews of Mature Quality Systems Sheppard, Mullin, Richter & Hampton LLP
Apr
19
2019
FDA Update: Recent Trends and a New Regime Sheppard, Mullin, Richter & Hampton LLP
Nov
3
2014
Agricultural Cooperative Antitrust Litigation Continues to Mushroom Sheppard, Mullin, Richter & Hampton LLP
Jul
8
2022
New Population-Based Option for the Maryland Primary Care Program in 2023 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
Oct
7
2022
California Expands Employees’ Right to Off-Duty Cannabis Use Sheppard, Mullin, Richter & Hampton LLP
Jan
14
2020
Day 1 Notes at the 2020 J.P. Morgan Healthcare Conference Sheppard, Mullin, Richter & Hampton LLP
Feb
28
2020
Federal Circuit Changes the Game for Selling Single-API Drugs to the Government Sheppard, Mullin, Richter & Hampton LLP
Apr
6
2020
CMS “Hospitals Without Walls” Waiver: Looking To ASCs to Provide Relief Sheppard, Mullin, Richter & Hampton LLP
May
15
2020
Not So Fast – FDA Retracts Authorization for Some Respirators Made in China Sheppard, Mullin, Richter & Hampton LLP
Dec
13
2023
Federal Circuit Evaluates Impact of the Final Written Decision (FWD) in a Parallel Inter-Partes Review (IPR) on District Court’s decision of Invalidity and Infringement Sheppard, Mullin, Richter & Hampton LLP
Jan
18
2024
Federal Circuit Affirms Skinny Label Carve Outs Sheppard, Mullin, Richter & Hampton LLP
Feb
29
2024
District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute Sheppard, Mullin, Richter & Hampton LLP
Sep
30
2020
A Year of Living Dangerously: 2020 and Maneuvers on the 340B Drug Pricing Program Battlefield 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
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
Apr
30
2021
New York State Legalizes Recreational Marijuana: What Employers Need to Know Sheppard, Mullin, Richter & Hampton LLP
Sep
17
2021
SAFE Banking Act of 2021: Where Are We on Cannabis Banking Change? Sheppard, Mullin, Richter & Hampton LLP
Dec
13
2021
Health Law Policy Heading Into 2022 At The ABA Health Law Summit 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
 

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