Searching Content indexed under Food and Drugs Law by Duane Morris LLP ordered by Published Date Descending.
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FDA Warns Florida Company: CBD Oil Is Not A Dietary Supplement
The letter focuses on Alternative's allegedly impermissible representation of 2-amino-5 methylheptane and Octodrine as a dietary ingredient in certain products.
United States
14 Oct 2019
New CMS Final Rule Strengthens Enforcement Authorities To Bolster Fraud And Abuse Prevention
The goal for CMS is to keep those providers and suppliers that have committed fraud out of the federal healthcare programs.
United States
11 Oct 2019
Ninth Circuit Punts On Interstate Transportation Of Hemp
Duane Morris will continue to monitor this case and will provide updates when the Idaho state courts issue their rulings.
United States
26 Sep 2019
Cannabis Vapor Sales Fall In Midst Of Health Scare, Though CDC Revises Scope Of Inquiry
Over the last few weeks, numerous media reports have focused on the alleged though unverified link between vaping products and certain health-related issues...
United States
26 Sep 2019
FTC Warning Letters And Reports Of Vaping-Related Illnesses Hit Cannabis Industry
This week's warning letters by the FTC coincide with unsubstantiated reports about a possible link between cannabis vaping and health conditions, in particular lung illnesses.
United States
25 Sep 2019
BYOD And eCOA: A Match Made In Heaven?
Patient-focused drug development and the selection and development of Clinical Outcome Assessments (COA) continue to be a focus for the U.S. Food and Drug Administration (FDA).
United States
23 Sep 2019
DEA Announcement On Improving Access To Marijuana Research
On August 26, 2019, the Drug Enforcement Agency (DEA) issued a press release announcing "it is moving forward to facilitate and expand scientific and medical research for marijuana in the United States."
United States
4 Sep 2019
Much Of Oklahoma's $572 Million Opioid Case Likely To Be Replicated Elsewhere, But Unique Cause Of Action May Not
On August 26, 2019, Cleveland County, Oklahoma, District Judge Thad Balkman delivered his highly anticipated ruling in the state of Oklahoma's
United States
30 Aug 2019
OTC Personal Products Manufacturer Cited By FDA For Various Regulatory Violations
On August 20, 2019, the U.S. Food and Drug Administration announced that it had sent and posted a warning letter to an over-the-counter drug manufacturer citing "significant"
United States
29 Aug 2019
CMS Issues Proposed Regulations To Expand Open Payments System Reporting
In the Federal Register posted on August 14, 2019, the Centers for Medicare and Medicaid Services (CMS) published proposed regulations that, if finalized,
United States
28 Aug 2019
FDA Releases Guidance On REMS Modifications And Revisions
On July 9, 2019, the U.S. Food and Drug Administration (FDA) released a final guidance on changes to approved Risk Evaluation and Mitigation Strategies (REMS).
United States
23 Aug 2019
Hamburgers, Sushi And The Young At Heart
I had dinner with someone eating sushi.
United States
19 Aug 2019
After Legalization: Many Remain Imprisoned For Now-Legal Pot
Imagine for a moment that you are arrested for alcohol possession back when alcohol was illegal. Then, imagine you served a sentence in prison for that possession, perhaps
United States
19 Aug 2019
Trump Administration Proposes Rule Requiring Hospitals To Disclose Negotiated Rates With Insurers
The rule proposed by the Centers for Medicare and Medicaid Services (CMS) would require that all facilities licensed as hospitals within their respective states
United States
12 Aug 2019
FTC Issues Report On Its Authority Under Section 5 Of The FTC Act To Challenge Pharmaceutical Drug Price Increases
On June 24, 2019, in response to a directive from Congress, the Federal Trade Commission (FTC) issued a report to the House and Senate Appropriations Committees on the use of the FTC's
United States
30 Jul 2019
FDA Comments On The Public Hearing On Products Containing Cannabis And Cannabis-Derived Compounds And Extends Comment Period
At the U.S. Food and Drug Administration's (FDA) public hearing on May 31, 2019 (read more about the hearing), over 100 people presented to a panel of FDA stakeholders and to over 500 attendees.
United States
25 Jul 2019
Effort To Legalize Adult Use Of Marijuana Fails In New York State
On June 17, 2019, the New York Legislative session adjourned without passing a bill that would have legalized adult use cannabis in the state.
United States
12 Jul 2019
FDA Adds Useful Information To The ANDA Paragraph IV Certifications List For Better Transparency And Predictability
The U.S. Food and Drug Administration took another step to implement its Drug Competition Action Plan on June 18, 2019
United States
10 Jul 2019
Illinois Becomes The 11th State To Legalize Adult-Use Marijuana
On May 31, 2019, the Illinois General Assembly passed House Bill 1438, called the Cannabis Regulation and Tax Act. Governor J.B. Pritzker has stated he will sign the bill.
United States
7 Jun 2019
Supreme Court Rules That Judges Must Decide Preemption Of Failure-To-Warn Claims
On May 20, 2019, the Supreme Court of the United States issued a rare unanimous decision in Merck Sharp & Dohme Corp. v. Albrecht, et al., holding that judges, not juries,
United States
7 Jun 2019
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