Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Dentons ordered by Published Date Descending.
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Advertisers Slapped With Infringement Notices For Non-Compliant Advertising Of Therapeutic Goods
Advertisers are reminded the Therapeutic Goods Advertising Code 2018 (TGAC) was recently amended by the Therapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument 2019.
13 Sep 2019
The Therapeutic Goods Administration Flexes Its Enforcement Muscles
The TGA has successfully brought a claim against Peptide Clinics Australia Pty Ltd for non-compliance with the new advertising regime which includes higher penalties for therapeutic goods advertising offences.
United States
16 Aug 2019
ACCC Wins First 'Gun Jumping' Case Against Competing Life Science Companies
The Federal Court has issued a rebuke of competitors involved in a merger which cooperate or coordinate their conduct before the merger is complete.
20 May 2019
Life Sciences Newsletter - Slovenská Republika
Spoločnosti podnikajúce v oblasti life sciences pravidelne čelia novým výzvam súvisiacimi s aktuálnymi zmenami legislatívy.
22 Feb 2019
Buyer Beware: Swiss-Style Patent Claims And The Australian Life Sciences Industry
A recent Federal Court decision has confirmed the Australian approach to the infringement of Swiss-style patent claims. The decision serves as a useful reminder of:
17 Dec 2018
Reform Of Pharmaceutical Regulation In Kazakhstan
As of the end of 2017, active work on legislation change and update is going on in Kazakhstan in the area of healthcare and pharmaceutical business.
12 Dec 2018
CMS Relaxes E/M Documentation Requirements For Teaching Physicians
In the recently finalized calendar year (CY) 2019 Medicare Physician Fee Schedule (MPFS) Final Rule, CMS streamlined certain documentation requirements for evaluation and management (E/M) services.
United States
11 Dec 2018
Navigating Continuous Disclosure In The Life Sciences Sector
Continuous disclosure obligations cause difficulties for many listed organisations. These difficulties are further amplified in the life sciences sector ...
19 Nov 2018
GME Recommendations In The President's FY 2019 Budget Proposal
On February 12, 2018, the Trump administration released its Fiscal Year (FY) 2019 budget request. Published on an annual basis, presidential budget requests do not set the federal budget, but rather...
United States
12 Oct 2018
Regulatory Changes For Specialists In Veterinary Medicine
On September 5, 2018, the RF Government issued Executive Order No. 1851-r, which put before the State Duma a bill of amendments
Russian Federation
5 Oct 2018
New Powers For Russia's Ministry Of Industry And Trade
A reservation taking these powers away from Minselkhoz will also be incorporated into the Regulation on the Ministry of Agriculture of the Russian Federation.
Russian Federation
5 Oct 2018
New Therapeutic Goods Advertising Code: What You Need To Know
The Therapeutic Goods Advertising Code (Code) is the latest legislative instrument to be implemented as part of the Australian Government's response ...
20 Jul 2018
How To Submit Advertising Complaints About Therapeutic Goods
As part of the recent advertising reforms, the Therapeutic Goods Administration (TGA) has now become the single agency for therapeutic goods advertising complaints management.
12 Jul 2018
Peter Homberg Speaks About Germany's Decision To Legalize Medical Cannabis With LABIOTECH.Eu
In March 2017, the German parliament voted for the legalization of cannabis for medicinal purposes. This meant that many changes had to be made within its legislation.
European Union
19 Mar 2018
Life Sciences. Major Russian Legal Changes In The Second Half Of 2017
The Russian government has introduced a risk-oriented approach for scheduled inspections in the healthcare industry
Russian Federation
13 Mar 2018
New Therapeutic Goods Legislation: What You Need To Know
The Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 and the Therapeutic Goods (Charges) Amendment Bill 2017 passed through both Houses on 15 February 2018. The bills have yet to receive Royal Assent.
2 Mar 2018
FDA Begins To Update How It Regulates Software Used As A Medical Device
The US Food and Drug Administration (FDA) is considering changes to the regulatory pathways for software used as a medical device (SaMD).
United States
27 Feb 2018
Federal Circuit Rules Distribution Agreement May Be Invalidating 'Offer For Sale'
In a February 6, 2018, decision, a Federal Circuit panel reasoned that a pharmaceutical distribution agreement can qualify as an invalidating "offer for sale" ...
United States
22 Feb 2018
From 2020, Russia Will Introduce A Compulsory System For Tracking Pharmaceuticals From Manufacturer To End User
The RF Government will detail the specifications for these identifiers and the process for putting them on packaging in a separate document.
Russian Federation
14 Feb 2018
New Uniform Recall Procedure For Therapeutic Goods
The new version of the Uniform Recall Procedure for Therapeutic Goods (URPTG) was published on 3 October 2017. This version replaces its 2004 predecessor.
25 Jan 2018
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