Searching Content indexed under Food and Drugs Law by Arnold & Porter ordered by Published Date Descending.
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New Developments In DTC Television Advertising: Disclosing Prescription Drug List Prices
In May 2018, amidst mounting public discussion, the Department of Health and Human Services (HHS) released a sweeping document entitled "HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Cost."
United States
19 Sep 2019
Strengthened Transparency In The EU General Food Law Regulation
On 6 September 2019, Regulation (EU) 2019/1381 of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain
European Union
19 Sep 2019
Investing In Cannabis
For many companies in the start-­up phase of their different product offerings, the fast ­developing cannabis market in the UK is characterized
18 Sep 2019
The Trump Administration Drug Importation Action Plan
In the past, such proposals have largely been met with resistance by the FDA.
United States
5 Aug 2019
Update On The European MDR And IVDR (June 2019)
We set out below an update on the current state of play.
European Union
10 Jul 2019
Update On The EU Regulation Of CBD In Foods And Vaping
On 15 April we issued a client Advisory summarising the current regulatory environment in Europe and the US for foods and cosmetics containing cannabidiol (CBD).
5 Jul 2019
Lit Alerts—July 2019
The Second Circuit Court of Appeals recently affirmed the SDNY'S dismissal of suits against Bristol-Myers Squibb Co. and Pfizer Inc. on the ground that the suits asserted state-law claims that were preempted by the FDCA.
United States
5 Jul 2019
Ninth Circuit Interprets Section 1129(a)(3) Of The Bankruptcy Code, Affirming The Plan Of Reorganization For A Lessor Of Property Used To Grow Marijuana
One of the debtor real estate holding companies leased property to a company that used the property to grow marijuana.
United States
20 Jun 2019
USDA Issues Guidance On Hemp Legalization Following The 2018 Farm Bill
USDA's opinion identified four conclusions based on these provisions, each of which is explained below.
United States
4 Jun 2019
Arnold & Porter Discusses Bill On Banking Services For Marijuana-Related Firms
Depository institutions have been understandably reluctant to provide banking services to cannabis-related businesses in light of the significant (and costly) regulatory and compliance expectations that apply under the Bank Secrecy Act ...
United States
17 Apr 2019
EU Regulation Of CBD In Foods And Cosmetics
A new date for the vote has not been set yet.
16 Apr 2019
Life Sciences (UK) 2019
The regulation of medicinal products in the UK derives from EU legislation, principally Directive 2001/83/EC (the Directive), and Regulation (EC) 726/2004 (the EU Regulation).
15 Apr 2019
FDA, State, And Local Governments Act To Modernize The Regulation Of Sunscreen Products In The United States
In February 26, 2019, FDA published its long-awaited proposed rule, Sunscreen Products for Over-the-Counter Human Use (Proposed Rule).
United States
15 Mar 2019
FDA Efforts To Modernize Medical Software Regulation Continue
Consistent with FDA Commissioner Dr. Scott Gottlieb's and CDRH Director Dr. Jeffrey Shuren's efforts to modernize FDA's regulatory framework for medical technology software
United States
5 Mar 2019
CJEU Decision On Scope Of Skinny Labels
On 14 February 2019, the Court of Justice of the EU (CJEU) delivered its judgment in Case C-423/17 Netherlands v Warner-Lambert Company.
United States
21 Feb 2019
Agencies, States And Local Governments Respond To Congressional Legalization Of Hemp (Non-Psychoactive Cannabis)
On December 11, 2018, Congress took an initial step toward legalizing cannabis and to resolve
United States
15 Feb 2019
Revised Guidance On Implementation Of The EU Falsified Medicines Directive
The Falsified Medicines Directive 2011/62/EU (FMD) introduced a new requirement for safety features to appear on the packaging of all prescription-only medicinal products: a unique product identifier and an anti-tampering device (ATD).
United States
13 Feb 2019
HHS OIG's Proposed Rule: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals
On January 31, 2019, the Department of HHS Office of Inspector General released a Proposed Rule on Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of...
United States
11 Feb 2019
Amendments To UK Human Medicines Regulations 2012
On 18 January, a new statutory instrument, the Human Medicines (Amendment) Regulations 2019 (the Amending Regulations), which amend the Human Medicines Regulations 2012, was laid before Parliament.
24 Jan 2019
Transparency Of Pre-Clinical And Clinical Trial Data In The EU
This note sets out the current legislation and guidance documents that require disclosure of pre-clinical and clinical trial data in the European Union (EU).
European Union
24 Jan 2019
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