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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
25
Aug
FDA Notifies Congress of Framework for Long-Awaited Guidance on Laboratory Developed Tests and Issues Final Guidance on Companion Diagnostics Mintz
25
Aug
FDA Issues Draft Guidance on De Novo Process Barnes & Thornburg LLP
25
Aug
Medical Device Update: FDA Issues Draft Guidance on Streamlined De Novo Classification Process Morgan, Lewis & Bockius LLP
25
Aug
Prescription Drugs: Refocusing the False Claims Act Microscope on the Rest of the Transaction Mintz
25
Aug
Physicians Write Letter to FDA Regarding Biosimilar Naming Concerns McDermott Will & Emery
25
Aug
FDA’s Announced Framework for Regulating Laboratory Developed Tests (LDTs) Leaves Open Many Questions Covington & Burling LLP
22
Aug
Office of Inspector General (OIG) Finds Risk of Abuse in Specialty Pharmacy’s Per-Fill Fee Proposal Mintz
22
Aug
Pennsylvania Federal Judge Upholds Poaching Claims in Pharmaceutical Data Antitrust Case McDermott Will & Emery
21
Aug
Liquor License Lottery Drawing Application Period Opens for Florida Lowndes, Drosdick, Doster, Kantor & Reed, P.A.
21
Aug
Minnesota Drug Testing Law Does Not Apply to Employees Working Outside Minnesota Jackson Lewis P.C.
21
Aug
FDA Says “Fuhgeddaboudit” To Its Own Proposed Pre-Decisional IDE Process Barnes & Thornburg LLP
21
Aug
Second Circuit Clarifies the Use of Legal Presumptions of Consumer Confusion and Injury in Certain Lanham Act Cases Sheppard, Mullin, Richter & Hampton LLP
19
Aug
FDA Issues Final Guidance on "In Vitro Companion Diagnostic Devices" Covington & Burling LLP
19
Aug
FDA Issues Guidance for Drug & Device Companies’ Social Media Interactions McBrayer, McGinnis, Leslie and Kirkland, PLLC
18
Aug
The Food Fight Continues: Vermont AG Seeks to Dismiss Lawsuit Against GMO Labeling Law Mintz
18
Aug
Office of Inspector General (OIG) Issues Unfavorable Advisory Opinion to Specialty Pharmacy For Support Service Payments Giordano, Halleran & Ciesla, P.C.
18
Aug
CMS Re-Opens Open Payments System Mintz
17
Aug
CMS Finalizes Program Changes for Medicare Advantage and Prescription Drug Benefit Programs - Alert! Jackson Lewis P.C.
15
Aug
Circuits Split Over Legality of IRS Rule Mandating Tax Credits for Individuals Covered Through Federal Exchanges under the Affordable Care Act Greenberg Traurig, LLP
15
Aug
FDA Releases Guidelines for 12- Year Period of Reference Product Exclusivity for Section 351(a) Biologics Sterne, Kessler, Goldstein & Fox P.L.L.C.

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