January 23, 2021

Volume XI, Number 23

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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
24
Jun
Deadlines for FSMA Final Rules Loom -- Keep Your Eye on the FDA Armstrong Teasdale
23
Jun
Colorado Supreme Court Upholds Employers’ Right to Terminate for Use of Medical Marijuana During Nonworking Hours Wilson Elser Moskowitz Edelman & Dicker LLP
23
Jun
Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic Requirements for Promotional Communications Mintz
23
Jun
Bottled Water Sold at Pennsylvania Stores Recalled Due to Possible E. Coli Contamination Stark & Stark
22
Jun
Colorado Supreme Court Plays Debbie Downer for Medical Pot Users Foley & Lardner LLP
22
Jun
Court Again Rejects Alleged ‘Fraud on the FDA’ Theory of Implied Certification Liability McDermott Will & Emery
22
Jun
FDA Releases Guidance for Food Allergen Labeling Exemptions Morgan, Lewis & Bockius LLP
22
Jun
FDA Issues Draft Guidance on Factors to Consider When Making Benefit-Risk Determinations for IDEs Alert Barnes & Thornburg LLP
22
Jun
California Court Upholds Emotional Distress Award Due to Unannounced Random Drug Test Jackson Lewis P.C.
22
Jun
Colorado Supreme Court Okays Discharge of Medical Marijuana-Using Employee Proskauer Rose LLP
22
Jun
Medical Device Update: FDA Issues Draft Guidance on Benefit-Risk Determinations for IDEs Morgan, Lewis & Bockius LLP
22
Jun
Teva v. Sandoz – “Strange Brew” Boils Over Schwegman, Lundberg & Woessner, P.A.
22
Jun
MicroRNA Therapy Delivers Positive Result in Early Mesothelioma Treatment Test Schiff Hardin LLP
21
Jun
FDA Determines Artificial Trans Fat Are No Longer “Generally Recognized as Safe”; Must Be Removed From Human Food By June 2018 Mintz
20
Jun
Connecticut Drug Testing Statutes Do Not Apply To Hair Tests, Court Holds Jackson Lewis P.C.
19
Jun
Employer to Pay for Emotional Distress Triggered by Random Workplace Drug Testing Jackson Lewis P.C.
18
Jun
HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities Foley & Lardner LLP
18
Jun
Cepheid v. Roche Molecular Systems and Mayo Foundation: Denying Institution for Not Providing Sufficient Evidence of Inherency IPR2015-00255 Faegre Drinker
18
Jun
Coalition for Affordable Drugs v. Celgene Corp: Motion for Leave to File Motion for Sanctions IPR2015-01092, 01096, 01102, 01103 Faegre Drinker
17
Jun
Medical Marijuana Users Get Smoked by High Court of Colorado Barnes & Thornburg LLP

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