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
25
2023
Connecticut Follows in the Footsteps of Other Jurisdictions Requiring Registration of Pharmaceutical Representatives Sheppard, Mullin, Richter & Hampton LLP
Jul
19
2016
Forget About Vermont!: Congress Passes GMO “Labeling” Legislation Sheppard, Mullin, Richter & Hampton LLP
Nov
18
2020
Green Wave: The Latest Election Cycle Brings Hope for Standardized Cannabis Legalization Sheppard, Mullin, Richter & Hampton LLP
Nov
23
2020
Los Angeles County Restricts In-Person Dining Due to Surge in COVID-19 Cases 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
2
2021
340B Drug Pricing Discount Program Update: HRSA Now Demands That Drug Manufacturers Provide 340B Discounts To Contract Pharmacies Amid Ongoing Litigation Sheppard, Mullin, Richter & Hampton LLP
Sep
29
2021
Impact of NYC’s New Delivery Service Data Sharing Requirement Sheppard, Mullin, Richter & Hampton LLP
Feb
5
2014
Changes To California Title 24 Energy Use Requirements Effective July 1, 2014 Sheppard, Mullin, Richter & Hampton LLP
Jan
25
2019
TRICARE: Defense Health Agency Issues Request for Information Regarding Formulary Management – Submission Deadline: February 5, 2019 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
Jul
8
2022
New Population-Based Option for the Maryland Primary Care Program in 2023 Sheppard, Mullin, Richter & Hampton LLP
Apr
19
2019
FDA Update: Recent Trends and a New Regime Sheppard, Mullin, Richter & Hampton LLP
Nov
3
2014
Beginning to Close the POM Circle? – POM Wonderful and Drug Advertising: JHP Pharmaceuticals Sheppard, Mullin, Richter & Hampton LLP
Dec
23
2014
U.S. Patent and Trademark Office Clarifies “Patent Eligible Subject” Matter in its Recent Guidance in Light of Alice Sheppard, Mullin, Richter & Hampton LLP
Jan
23
2015
FDA Issues Guidance for Low-Risk General Wellness Products 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
4
2016
Second Circuit Narrowly Applies Supreme Court’s Decision in Omnicare 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
May
9
2024
Bridging the Gap: Cannabis Rescheduling to Align Policy with Research 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
 

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