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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
4
Aug
Ignorance is Bliss – for Teva re: Structural Obviousness in Patent Cases Schwegman, Lundberg & Woessner, P.A.
4
Aug
Commission Updates EU Medical Devices Borderline Manual Covington & Burling LLP
4
Aug
FDA Issues Updated Draft Guidance on Reporting Drug Samples Morgan, Lewis & Bockius LLP
3
Aug
EcoWater Systems LLC v. Culligan International Co., Inter Partes Review Still Difficult for Patent Owners McDermott Will & Emery
3
Aug
Dissent at the Patent Trial and Appeal Board (PTAB) Leads to … Unpatentability McDermott Will & Emery
2
Aug
Amneal Pharmaceuticals, LLC v. Endo Pharmaceuticals Inc., Denying Institution IPR2014-00361 Faegre Drinker
1
Aug
What’s New Under the Food Safety Modernization Act? Beveridge & Diamond PC
31
Jul
FDA Releases Details of New Framework for Laboratory Developed Tests Regulation Morgan, Lewis & Bockius LLP
31
Jul
FDA Finalizes Appeals Guidance on Section 517A of the Food, Drug, and Cosmetic Act Covington & Burling LLP
31
Jul
USPTO TRIPs Over Myriad-Mayo Guidance - Trade-related Aspects of Intellectual Property Rights Schwegman, Lundberg & Woessner, P.A.
31
Jul
Contractual Duty to Deal Does Not Equal Antitrust Duty to Deal McDermott Will & Emery
31
Jul
Energy Technology Connections - July 2014 Mintz
31
Jul
Intelligent Bio-Systems, Inc. v. Illumina Cambridge Limited, Final Written Decision IPR2013-00128 Faegre Drinker
31
Jul
A Compound Is Obvious Where Only Minor Changes to a Prior Art “Lead Compound” Are Required to Make the Claimed Compound McDermott Will & Emery
30
Jul
Obviousness Only Requires Reasonable Expectation of Success of One Compound Encompassed by Broad Genus Claims McDermott Will & Emery
30
Jul
European Commission Fines Servier and Five Generic Companies for Preventing Entry of Generic Versions of Blood Pressure Control Drug Covington & Burling LLP
30
Jul
The Race is on! Anxiously Waiting for the First U.S. Biosimilar to Cross the Finish Line Michael Best & Friedrich LLP
28
Jul
FDA Finalizes Guidance on the Evaluation of 510(k) Substantial Equivalence Covington & Burling LLP
28
Jul
FDA Denies Citizen Petition’s Request to Ban Marketing of Non-Absorbable Surgical Mesh Products for Transvaginal Repair of Pelvic Organ Prolapse Covington & Burling LLP
25
Jul
The FDA’s Informed Consent Draft Guidance: Insights and Challenges for IRBs, Clinical Investigators and Sponsors Faegre Drinker

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