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
Aug
13
2020
340B Update: Appellate Court Upholds 340B Payment Reduction as CMS Proposes Further Reductions for 2021 [Podcast] K&L Gates
Apr
27
2020
340B Update: CMS Opens Acquisition Cost Data Survey for 340B Hospitals K&L Gates
Sep
26
2020
340B UPDATE: Congress and the Administration Respond to Drug Manufacturers' 340B Contract Pharmacy Actions K&L Gates
Jul
7
2021
340B Update: Delaware Court Denies 340B Program Statute Requiring Contract Pharmacy Arrangements K&L Gates
Jan
18
2017
340B Update: HRSA Finalizes 340B Pricing & Penalties for Drug Manufacturers K&L Gates
Jul
21
2020
340b Update: HRSA Indicates It Lacks Authority to Enforce 340b Program Guidance K&L Gates
May
26
2021
340B Update: HRSA Issues Final Warning Letter to Pharmaceutical Manufacturers that Their Contract Pharmacy Actions Violate 340B Statute K&L Gates
Dec
22
2020
340b Update: Recent Supreme Court Ruling May Curtail 340b Program Discriminatory Pricing K&L Gates
Jul
8
2021
340B Update: Supreme Court Accepts Certiorari in 340B Payment Reduction Case K&L Gates
May
7
2015
340B ‘Mega-Guidance’ Arrives at Office of Management and Budget McDermott Will & Emery
Dec
16
2021
3D Printing Medical Devices at the Point of Care — FDA Invites Feedback Foley & Lardner LLP
Aug
7
2014
3D-Matrix, Ltd. v. Menicon Co., Ltd., Denying Institution of Inter Partes Review IPR2014-00398 Faegre Drinker
May
27
2020
3D-Printed Masks, Disinfecting Devices, and Simplified Ventilators – a Sampling of Tech Advances in the Age of COVID-19 from California Universities Sheppard, Mullin, Richter & Hampton LLP
Sep
16
2015
3D-Printed Prescription Drugs a Huge Stride Forward for Personalized Medicine Wilson Elser Moskowitz Edelman & Dicker LLP
Dec
21
2019
4 Things Hemp Lawyers Want You to Know Before You Sell CBD Products Ward and Smith, P.A.
Apr
24
2020
4/20 Federal Ruling: Marketer Can Be Liable For Dispensarys’ TCPA Violations Squire Patton Boggs (US) LLP
Sep
24
2022
413 Pounds of Concealed Marijuana Intercepted by Cincinnati CBP U.S. Customs and Border Protection
Feb
11
2019
45 States Now Have Biosimilar Substitution Laws Mintz
Sep
28
2022
4th Quarter 2022 Quick Hits for Plan Sponsors and Administrators Jackson Lewis P.C.
Oct
31
2019
5 Key Reasons to Ensure Ongoing Compliance with State Distributor Licensing Requirements Mintz
Aug
13
2021
5 Keys to Passing an FDA Inspection or Audit Oberheiden P.C.
Feb
6
2024
5 Trends to Watch: 2024 Class Actions Greenberg Traurig, LLP
Jun
15
2021
50 State Map of MAC Laws – Can PBMs No Longer Rely on ERISA Preemption to Avoid Certain State Laws? Foley & Lardner LLP
Apr
18
2019
51st Meeting of the Codex Alimentarius Committee on Food Additives (CCFA51) Finalizes Most of Its Backlog on Food Additives Keller and Heckman LLP
Jan
9
2024
5th Circuit Issues Blistering Critique of FDA’s Handling of PMTAs for E-Cigarettes Keller and Heckman LLP
Aug
31
2016
6-Month Notice from a Biosimilar Sponsor Always Required — Says Federal Circuit Mintz
Jan
10
2014
60 Minutes’ “The Cleantech Crash”: CBS News Program’s Criticism of the Clean Energy Industry and the Reaction of Clean Energy Advocates Mintz
Feb
17
2016
60-Day Rule Is Final: Assessing Your Organization’s Safeguards Morgan, Lewis & Bockius LLP
 

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