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
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
Jan
2
2024
The Intertwining Nature of Motivation to Combine and Reasonable Expectation of Success Sheppard, Mullin, Richter & Hampton LLP
Jan
29
2024
2024 Top-of-Mind Issues for Life Sciences Companies Sheppard, Mullin, Richter & Hampton LLP
Feb
6
2024
FDA’s Office of Prescription Drug Promotion Issues Its First Untitled Letter of the Year to Novartis for Misleading Statement Relating to KISQALI® Sheppard, Mullin, Richter & Hampton LLP
Feb
20
2024
New Bills Being Served Up That May Soon Impact Food Retailers and Manufacturers Sheppard, Mullin, Richter & Hampton LLP
Mar
19
2024
Time to Refresh? FDA Issues Draft Guidance on Key Information and Informed Consent 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
May
8
2021
FDA Proposes Risk-Based and Remote Inspection Strategies in New Report 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
Aug
25
2022
Healthcare Reforms Under the IRA: Expanding Access to Care 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
Mar
20
2023
FDA Draft Guidance Signifies Acceptance of the Term “Milk” to Describe Plant-Based Alternatives Sheppard, Mullin, Richter & Hampton LLP
Feb
12
2020
Federal Circuit Revolutionizes Country of Origin Analysis for Pharmaceuticals 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
Jan
21
2024
FDA Issues Final Rule and Guidance on Direct-To-Consumer Prescription Drug Advertisements Sheppard, Mullin, Richter & Hampton LLP
Jun
23
2020
FDA Issue Guidance on Manufacturing Drugs, APIs during COVID-19 Sheppard, Mullin, Richter & Hampton LLP
Mar
9
2024
Oregon Prescription Drug Price Transparency Act in Limbo 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
Jul
2
2010
US Patent Office Expands Green Technology Accelerated Examination Program - More categories of invention are now eligible for expedited processing Sheppard, Mullin, Richter & Hampton LLP
 

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