August 13, 2020

Volume X, Number 226

August 12, 2020

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August 11, 2020

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August 10, 2020

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Biotechnology, Life Sciences, Food and Drug Law News

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.

Date Title Organization
16
Jan
FDA Proposes to Apply Risk-Based Framework to Accessory Devices Mintz
16
Jan
Fifth Circuit Holds That Product Development Protocol Has Same Preemptive Effect As Premarket Approval Covington & Burling LLP
15
Jan
Pharmacy Qui Tam Based On U&C Price Billing Survives Motion to Dismiss Mintz
15
Jan
CMS Releases EHR (Electronic Health Records) Incentive Program Data Covington & Burling LLP
14
Jan
Torrent Pharmaceuticals Limited v. Merck Frosst Canada & Co.: Denying Petitioner’s Request for Rehearing of Decision on Institution IPR2014-00559 Faegre Drinker
14
Jan
New Jersey Pharmaceutical Company Agrees to Pay $39 Million to Settle Alleged Anti-Kickback Violations Tycko & Zavareei LLP
14
Jan
Latest Proposal to Repeal Medical Device Excise Tax Gains Traction Covington & Burling LLP
13
Jan
CDRH Releases 2015 Guidance Document Agenda, Announces Retrospective Guidance Document Review -- Center for Devices and Radiological Health Covington & Burling LLP
12
Jan
FDA Issues Draft Guidance on Transfer of a 510(k) Clearance Barnes & Thornburg LLP
12
Jan
EEOC Targets Incentive-Based Wellness Programs as Violating the ADA and GINA Gonzalez Saggio & Harlan LLP
12
Jan
Inching Closer to the First Biosimilar Approval in the U.S. Michael Best & Friedrich LLP
9
Jan
FDA Is Exploring Options for Regulating Next Generation Sequencing Diagnostic Tests Covington & Burling LLP
9
Jan
Second Circuit To Hear Expedited Appeal in “Product Hopping” Suit McDermott Will & Emery
8
Jan
FDA Issues Draft Guidance on 510(k) Transfers Covington & Burling LLP
6
Jan
FSIS’s New Year’s Resolution: Ensuring Consumers Are Aware of Solutions Added to Meat and Poultry -- Food Safety and Inspection Service Morgan, Lewis & Bockius LLP
5
Jan
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
5
Jan
Oklahoma and Nebraska Challenge Colorado’s Amendment 64: Legalized Marijuana The National Law Review / The National Law Forum LLC
5
Jan
Menu and Vending Machine Labeling – Final Rule Finally Released Michael Best & Friedrich LLP
5
Jan
Be Mindful of Your Claims in Divisional Applications and Patents in South Africa Michael Best & Friedrich LLP
4
Jan
President Signs Act Authorizing $5.4 Billion in Emergency Funding to Combat Ebola Covington & Burling LLP

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