September 27, 2020

Volume X, Number 271

September 25, 2020

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September 24, 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
4
Feb
FDA Issues Draft Guidance on General Wellness Devices and on Medical Device Accessories McDermott Will & Emery
4
Feb
New York Targets Popular Supplements: Whistleblower Mahany Law
3
Feb
Filthy Pharma – Whistleblowers and Current Good Manufacturing Practices Mahany Law
3
Feb
Are Lower Cost Drugs Less Effective? It May Depend on the Patient’s Perspective. Epstein Becker & Green, P.C.
2
Feb
FDA Issues Draft Guidance on Medical Device Accessories Barnes & Thornburg LLP
2
Feb
EMA Transparency Policy – EMA Launches Public Consultation On The Publication Of Information Under The New EU Clinical Trials Regulation Covington & Burling LLP
30
Jan
Federal Circuit Upholds PTO Refusal to Withdraw Unauthorized Terminal Disclaimer McDermott Will & Emery
30
Jan
Practice Considerations Post Teva v. Sandoz Sterne, Kessler, Goldstein & Fox P.L.L.C.
30
Jan
No Declaratory Jurisdiction Without Biosimilarity Application on File with FDA McDermott Will & Emery
30
Jan
Inherency Requires Factual Evidence that a Limitation Is Necessarily Present or Is the Natural Result McDermott Will & Emery
30
Jan
Court Greenlights “Usual and Customary” Medicare Fraud Case Mahany Law
30
Jan
Statute Intended to Close Deepsouth Loophole Given Broad Interpretation: Promega Corp. v. Life Techs. Corp. McDermott Will & Emery
30
Jan
Even Further Down the Rabbit Hole: New EU Legislation Adds to GMO Quagmire Mintz
29
Jan
Supreme Court Holds Claim Construction Facts Are Subject to Clear Error Review Honigman Miller Schwartz and Cohn LLP
29
Jan
Federal Circuit to Myriad: Neither DNA Primers nor Comparing Gene Sequences Are Patent-Eligible Subject Matter McDermott Will & Emery
29
Jan
Brazil Mailbox Litigation Update: Good News to Start the Year for the Pharmaceutical Industry Michael Best & Friedrich LLP
28
Jan
Medical Device Update: FDA Releases General Wellness Products and Device Accessories Guidance Documents Morgan, Lewis & Bockius LLP
28
Jan
Pennsylvania Court Strengthens Rejection of “Every Breath” Theory re: Asbestos Exposure Steptoe & Johnson PLLC
27
Jan
Telemedicine has an Unlikely Ally: The Federal Trade Commission (FTC) Epstein Becker & Green, P.C.
27
Jan
Summary Report of European Commission’s mHealth Consultation Published Covington & Burling LLP

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