Searching Content indexed under Food and Drugs Law by Duane Morris LLP ordered by Published Date Descending.
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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
The Looming Crisis – Illegal Administration Of Schedule II Controlled Substances In Nursing Homes
Not a week goes by without some mention of the opioid crisis and opioid litigation, including the recent settlement proposal by Purdue Pharma to pay $270 million ...
United States
4 Jun 2019
With Hemp Legalized By 2018 Farm Bill, Patent And Trademark Office Issues New Guidelines
On May 2, 2019, the United States Patent and Trademark Office (USPTO) made available a new examination guide aimed at clarifying
United States
22 May 2019
New Jersey Appellate Division Finds Employee Stated Viable Claim Against Employer For Failure To Accommodate Off-Duty Use Of Medicinal Marijuana
In a recent decision approved for publication on March 27, 2019, the New Jersey Appellate Division addressed an issue of first impression: whether an employee can state a claim
United States
15 May 2019
UCANN's Liquid Cannabis Patent Survives Section 101 Challenge By Pure Hemp; Judge Questions Novelty, Usefulness And Nonobviousness
On April 17, 2019, the Federal Court in the District of Colorado denied Pure Hemp's motion to dismiss United Cannabis Corporation's (UCANN) patent for failing to claim "patentable subject matter."
United States
8 May 2019
FDA Announces Its Next Steps For Cannabis Products
With the enactment of the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill), hemp-derived CBD appeared to be on the table for marketing all across the country.
United States
17 Apr 2019
Anwalt in Vietnam Dr. Oliver Massmann – Arzneimittel- ASEAN im Kontext – Kommt nach Vietnam – Ihr werdet gerecht behandelt – Denkt nicht weiter an Indonesien
Laut einer neu verabschiedeten Regelung in Jakarta, benötigt jedes nicht in Indonesien hergestellte Medikament eine zwingende Lizenz. Während für wirtschaftliche ...
11 Apr 2019
The 2018 Farm Bill Preserves FDA Right To Regulate Cannabis Products
Last year was a record year for cannabis. Canada passed the Cannabis Act, making adult-use cannabis legal there. The FDA approved a cannabidiol-based medicine, Epidiolex.
United States
11 Feb 2019
Is New Hampshire The Next State To Legalize Cannabis?
The first public hearing on New Hampshire House Bill 481, which would legalize the adult use of cannabis in the state, is scheduled for February 5, 2019.
United States
11 Feb 2019
FDA Issues Final Guidance On Data Integrity And Compliance With Drug CGMP
Data integrity means complete, consistent and accurate recording of data. This requires an original or true copy of contemporaneously recorded data that is attributable to a specific individual and is legible and accurate.
United States
18 Jan 2019
DOJ Implements 2018 Granston Memo On False Claims Act
In early 2018, the U.S. Department of Justice announced a new policy encouraging prosecutors handling False Claims Act (FCA) ...
United States
10 Jan 2019
FDA Withdraws Proposed Generic Drug Labeling Rule
The U.S. Food and Drug Administration recently announced it will withdraw a proposed rule that would have required generic drug manufacturers to independently update their drug labels...
United States
27 Dec 2018
Final 2018 Farm Bill Proposes Hemp To Be Removed From Controlled Substances Act; CBD Derived From Hemp To Be Regulated By States
Note: The Senate passed this bill on December 11, 2018; the House of Representatives passed it on December 12, 2018. Duane Morris will be following further developments and issuing updates.
United States
17 Dec 2018
FDA Publishes Redraft Of 510(K) Third Party Review Program
Section 523 of the Federal FD&C Act codifies the 510(k) Third Party Review Program, which authorizes certain qualified third parties to conduct the initial review of premarket notification submissions...
United States
23 Nov 2018
CDER's New MAPP On Risk-Based Site Selection Model For Routine Inspections
The list is developed from inputting sites from CDER's Catalog of Manufacturing Sites into the SSM
United States
15 Nov 2018
SUPPORT Act Expands Sunshine Act Disclosure Requirements, Covered Recipients
One of the provisions of this lengthy bipartisan package of bills includes an expansion of the disclosure requirements initially imposed by the Physician Payments Sunshine Act.
United States
26 Oct 2018
SUPPORT Act Expands Sunshine Act Disclosure Requirements
On October 24, 2018, President Donald Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), ..
United States
25 Oct 2018
FDA Rolls Out Pilot Of New Quality In 510(k) "Quik" Review Program
On September 6, 2018, the FDA launched an alternate to the Traditional 510(k) for submitting a Premarket Notification (510(k)).
United States
23 Oct 2018
FDA Unveils New Quality in 510(k) "Quik" Review Program Pilot
According to the FDA, one of its purposes is to evaluate whether use of the FDA's free eSubmitter software will produce well-organized submissions that can be reviewed more efficiently.
United States
23 Oct 2018
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