Biotech, Food & Drug

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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.

National Law Review Cannabis TwitterFor hourly updates on the latest news about biotech, food & drug, and cannabis laws, regulations, and legislation, be sure to follow our Cannabis X (formerly Twitter) feed, and sign up for complimentary e-news bulletins.

Recent Biotechnology, Food & Drug Administration FDA News

Title
Publication Date Organization
Feb
7
2015
21st Century Cures Discussion Draft Act Proposes Changes to Medical Device Regulation Covington & Burling LLP
Dec
15
2016
21st Century Cures: Examining Provisions for Streamlining FDA Regulations for Clinical Research in Title III McDermott Will & Emery
Jan
6
2017
21st Century Cures: Food and Drug Administration (FDA) Drug Provisions McDermott Will & Emery
Dec
16
2016
21st Century Cures: Modernizing Public and Private Research McDermott Will & Emery
Aug
9
2018
23 California DAs Obtain $1.5 Million Settlement for Deceptive Biodegradable Claims Keller and Heckman LLP
Sep
29
2014
3 Ways to Protect Our Farmers This Fall U.S. Department of Labor
May
13
2016
3-D Printing and the Regulatory Future of Home Remedies: Pharma to Table New York University School of Law
Mar
10
2015
3-D Printing Guidance Only a B-List Priority for FDA Epstein Becker & Green, P.C.
Dec
17
2014
30 Projects Announced to Support Michigan Specialty Crop Growers Varnum LLP
Feb
6
2020
30,000 Cannabis Users’ Data Exposed Robinson & Cole LLP
Feb
24
2020
340B Ceiling Price Transparency – HRSA Now Requiring Pharmaceutical Manufacturers to Issue Refunds to Covered Entities for Overcharges Mintz
Aug
16
2017
340B Covered Entities Beware: CMS Proposes Drastic Drug Reimbursement Rate Cuts Polsinelli PC
Feb
2
2023
340B Covered Entities May See Access Changes to Contrast Media, Radiopharmaceuticals and Other Products McDermott Will & Emery
Apr
3
2019
340B Drug Ceiling Prices Now Available Dinsmore & Shohl LLP
Jul
2
2021
340B Drug Pricing Discount Program Update: HRSA Now Demands That Drug Manufacturers Provide 340B Discounts To Contract Pharmacies Amid Ongoing Litigation Sheppard, Mullin, Richter & Hampton LLP
Mar
19
2021
340B Drug Pricing Program 2021 Outlook [PODCAST] K&L Gates
Jul
19
2018
340B Drug Pricing Program Litigation Update: American Hospital Association, Et Al. v. Azar Sheppard, Mullin, Richter & Hampton LLP
Apr
18
2016
340B Drug Pricing Program: HRSA Reopens Comment Period for 2015 Proposed Rule Squire Patton Boggs (US) LLP
Sep
15
2014
340B Federal Drug Pricing Program September Update: Self-Disclosures McDermott Will & Emery
Dec
19
2022
340B Hospital Reimbursement Update – Underpayments and the Need to Act Now Polsinelli PC
Mar
31
2021
340B in 2021: What Covered Entities and Their Partners Need to Know Now Recap McDermott Will & Emery
Feb
28
2020
340B In The Spotlight – CMS 340B Acquisition Cost Survey Proposal & President’s Budget Polsinelli PC
May
28
2014
340B Orphan Drug Rule Invalid Faegre Drinker
Dec
13
2019
340B Program-Participating Hospitals Object to CMS’s Proposed Cuts to 340B Program Reimbursement: CMS’s Recent Information Collection Request Sheppard, Mullin, Richter & Hampton LLP
Aug
4
2020
340B Rate Cuts Are Legal, D.C. Circuit Court Holds Mintz
May
22
2019
340B Rate Cuts: DC Court Enjoins and Remands CMS’ 2018 and 2019 Reductions for Hospital Outpatients Foley & Lardner LLP
Jun
23
2014
340B Registration Changes: Re-enrollment of Currently Participating Facilities and Eligibility Based on Amended Cost Reports McDermott Will & Emery
Apr
12
2024
340B Remedy Rule and Medicare Advantage Rates: Navigating Shifting Payments McDermott Will & Emery
 

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