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 Sort descending
Dec
15
2014
Sunshine Act Update: CMS Streamlines Reporting for CME-Related Payments in 2016 Morgan, Lewis & Bockius LLP
Mar
17
2015
FDA Issues Final Guidance on Reprocessing of Medical Devices Morgan, Lewis & Bockius LLP
Jun
22
2015
FDA Releases Guidance for Food Allergen Labeling Exemptions Morgan, Lewis & Bockius LLP
Aug
5
2015
Federal Judge Strikes Down Law That Criminalized “Interference with Agricultural Production” Morgan, Lewis & Bockius LLP
Nov
16
2015
Food and Drug Administration Releases New Food Safety Rules Morgan, Lewis & Bockius LLP
Feb
9
2016
FDA Issues Draft Guidance on ‘Emerging Signals’ Morgan, Lewis & Bockius LLP
May
19
2016
FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices Morgan, Lewis & Bockius LLP
May
25
2016
New FDA Draft Guidance on Use of Electronic Health Record Data in Clinical Investigations Morgan, Lewis & Bockius LLP
Jul
6
2016
Apotex—Biosimilars Must Provide 180-Day Marketing Notice After FDA Approval Morgan, Lewis & Bockius LLP
Nov
14
2016
Top Takeaways from FDA Draft Guidance on Software as Medical Device Morgan, Lewis & Bockius LLP
Apr
25
2013
Federal Energy Regulatory Commission (FERC) Proposes to Approve Overhaul of North American Electric Reliability Corporation (NERC) Cybersecurity Standards Morgan, Lewis & Bockius LLP
Dec
25
2013
Reform Opens Door to Private Investment in Mexico’s Energy Sector Morgan, Lewis & Bockius LLP
Aug
4
2014
FDA Issues Updated Draft Guidance on Reporting Drug Samples Morgan, Lewis & Bockius LLP
Jun
12
2015
Food Service Company Settles Whistleblower Suit Alleging Overcharging and Poor Performance of Contracts with DC School System for $19.4 Million Morgan, Lewis & Bockius LLP
Jan
7
2016
2015 FDA Wrap-Up and 2016 Regulatory Priorities Morgan, Lewis & Bockius LLP
May
12
2016
FDA Will Reconsider Meaning of “Healthy” Morgan, Lewis & Bockius LLP
Aug
25
2016
D.C. Circuit Court Strikes FDA Preapproval for Tobacco Product Labeling Changes Morgan, Lewis & Bockius LLP
Jul
26
2017
Menu of the Day: Menu Labeling Requirements Morgan, Lewis & Bockius LLP
Mar
24
2012
Personalized Medicine Patents Rejected by U.S. Supreme Court Morgan, Lewis & Bockius LLP
Jun
24
2014
Food and Drug Administration (FDA) to Cease Active Regulation of Medical Device Data Systems (MDDS) and Other Health IT Devices Morgan, Lewis & Bockius LLP
Apr
15
2015
FDA Issues First E-Cigarette Warning Letters Morgan, Lewis & Bockius LLP
Aug
6
2015
Clinical Trial Data: The New EU Regime Morgan, Lewis & Bockius LLP
Jan
20
2016
Use of Term ‘‘Natural’’ in Labeling of Human Food Products: Comment Period Extension and Update Morgan, Lewis & Bockius LLP
Feb
13
2016
USDA Announces New Standards to Reduce Salmonella and Campylobacter in Poultry Morgan, Lewis & Bockius LLP
Mar
10
2016
FDA and Amarin Reach Settlement on First Amendment and Off-Label Statements Morgan, Lewis & Bockius LLP
Oct
4
2016
FDA Will Exercise Enforcement Discretion for “Healthy” Food Claims Morgan, Lewis & Bockius LLP
May
31
2017
Menu Labeling and Passive Federal Preemption Morgan, Lewis & Bockius LLP
Jul
12
2017
USDA Seeks Lightning-Speed Industry Input for Upcoming Proposed Bioengineered Food Disclosure Rule Morgan, Lewis & Bockius LLP
 

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