Searching Content indexed under Food and Drugs Law by Sheppard Mullin Richter & Hampton ordered by Published Date Descending.
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CBD Industry Beware: The False Labeling Class Action Has Arrived
Last week, in what may be the first of its kind, a putative class of Massachusetts consumers filed a false labeling class action complaint against Global Widget LLC
United States
15 Oct 2019
New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning
On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement...
United States
8 Oct 2019
Tips For When To Consider Legal Review Of Quality System Investigations
As a lawyer with extensive experience in good manufacturing practice (GMP) issues, clients will ask me to review complex Quality System investigations.
United States
27 Sep 2019
FDA's New Safety And Performance Based Pathway For Medical Devices Reflects A More Modern Approach To Finding Substantial Equivalence
On September 19, 2019, FDA issued a guidance document, "Safety and Performance Based Pathway," describing an optional pathway for medical devices ...
United States
26 Sep 2019
How FDA Considerations Impact Food And Beverage Acquisitions
When considering an acquisition of a food and beverage company, potential buyers of a company or its assets should pay particular attention to U.S. Food and Drug Administration requirements
United States
19 Aug 2019
Is Prescription Drug Pricing The Cure For Partisanship?
The bill passed out of committee by a 19-9 vote on July 25th.
United States
2 Aug 2019
Don't Spill Your Trade Secrets: Protecting Your Competitive Advantage In The Food And Beverage Industry (Part 1 Of 2)
In the race to get new products to market, food and beverage businesses sometimes neglect their critically important intangible assets — their valuable trade secrets.
United States
29 Jul 2019
What's In The Bottle? FDA Announces New Blockchain Pilot Program For Tracking Drug Distribution
Where does my prescription come from? Has it been altered or diluted? Can I trust the label? With millions of prescriptions filled each year
United States
23 Jul 2019
Regulating E-Cigarettes Remains "Top Priority" For FDA
On July 10, 2019 Ned Sharpless, M.D., the Acting Commissioner of the Food and Drug Administration (FDA) issued a statement reaffirming FDA's commitment to overseeing
United States
22 Jul 2019
The U.S. Trademark Office Opens The Door To Registering Certain Cannabis Trademarks
On May 2, 2019, the United States Trademark Office issued new Examination Guidelines for goods and services associated with cannabis and cannabis-derived products and services legalized under the 2018 Farm Bill.
United States
18 Jun 2019
Location Matters – Manufacturing Insights From FDA's Annual Report On Drug Quality
The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) within the US Food and drug Administration (FDA) ...
United States
4 Jun 2019
AAFCO Issues Updated Guidelines Regarding Hemp In Animal Food
On May 1, 2019, AAFCO provided updated guidelines regarding the use of hemp in animal food, including how this market is affected by the Agricultural Improvement Act of 2018
United States
27 May 2019
Patentees and inventors of cannabis compounds may be happy to learn a district court in Colorado recently held that, based on the record before it, U.S. Patent No. 9,730,911
United States
15 May 2019
Years In The Making: The Health Resources & Services Administration Launches A Website To Increase Pricing Transparency In The 340B Program
If you overheard Medicaid providers breathe audible sighs of relief on April Fool's Day, it may be because on April 1, 2019
United States
10 May 2019
FDA Issues Warning Letter To Lab Marketing Three Laboratory-Developed Tests
In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic
United States
6 May 2019
FDA Update: Recent Trends And A New Regime
Norman E. (Ned) Sharpless, M.D., recently took the helm as Acting Commissioner of the US Food and Drug Administration (FDA). Dr. Sharpless most recently served as the director of the National Cancer
United States
6 May 2019
The Farm Bill's Impact On Hemp And CBD – And How Some States Are Reacting
While the legal landscape continues to evolve in the cannabis industry, making entry into the space a potentially risky proposition, the passage of the Agriculture Improvement Act of 2018 ...
United States
12 Mar 2019
HHS Proposes Rule To Eliminate Safe Harbor For PBM Drug Rebates
On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the "OIG") published in the Federal Register...
United States
18 Feb 2019
Compliance Risk Alert: Opioid Warning Letters Issued By The U.S. Department Of Justice Target Prescribers
U.S. Attorney's Offices ("USAOs") across the country are issuing warning letters to physicians and other prescribers (collectively, "Prescribers") cautioning them about their opioid prescribing
United States
13 Feb 2019
Cannabis Regulation Is The New Frontier In Real Estate And Land Use Control
California has positioned itself as a leader on emerging cannabis policy.
United States
31 Jan 2019
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