FDA/USDA Regulations - Biotech/Drug Laws

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.

For hourly updates on the latest news about biotech, food & drug, and cannabis laws, regulations, and legislation, be sure to follow our Cannabis Twitter feed, and sign up for complimentary e-news bulletins.

Date	Title	Organization
20 May	EU Seeks Input on Policy for Plants Developed Using New Genomic Techniques	ArentFox Schiff LLP
20 May	The VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to Fruition	Epstein Becker & Green, P.C.
20 May	Recent FDA Enforcement Action Colors Regulatory Landscape for Delta-8 THC Products	Epstein Becker & Green, P.C.
20 May	Implications of the Use of the Defense Production Act in the U.S. Supply Chain	Bradley Arant Boult Cummings LLP
19 May	FDA Updates Agricultural Water Protocol	Keller and Heckman LLP
19 May	Expert Witness Case Complexity & Vetting – Episode 36 [Podcast]	IMS Consulting & Expert Services
19 May	FDA White Paper Signals Shift to Performance-Based Reviews of Mature Quality Systems	Sheppard, Mullin, Richter & Hampton LLP
18 May	France Asks Providers to Give Updated R-Nano Declaration Numbers to Customers upon Request	Bergeson & Campbell, P.C.
18 May	BridgeBio Transaction Reflects Healthy Market for FDA Priority Review Vouchers	Proskauer Rose LLP
18 May	FDA Issued Enforcement Discretion Measures for Infant Formula	Squire Patton Boggs (US) LLP
18 May	House Bill To Give FDA More Funding to Address Formula Shortage	Keller and Heckman LLP
17 May	Episode 21: Putting People First in Behavioral Health Reform [PODCAST]	Foley & Lardner LLP
17 May	FDA Releases Guidance on Infant Formula Enforcement Discretion Policy	Keller and Heckman LLP
17 May	California Cannabis Farmers May Finally Get Some Relief	Sheppard, Mullin, Richter & Hampton LLP
16 May	FDA Finalizes Guidance on Reducing Microbial Hazards in Seed for Sprouting	Keller and Heckman LLP
13 May	FDA Expresses Displeasure with Consumer Products Containing Trendy Cannabis Ingredient Delta-8 THC	Mintz
13 May	A New(ish) Chemical Excise Tax Effective July 2022	Proskauer Rose LLP
13 May	'Fresh, Local, Quality' — How Unverifiable Opinions Evade False Advertising Claims	Katten
12 May	FDA Works to Improve Supply of Formula Products	Keller and Heckman LLP
12 May	Recall Roundup: April 2022	Hunton Andrews Kurth