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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Smart & Biggar ordered by Published Date Descending.
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1
Regulations Will Require Hospitals To Report Serious Adverse Drug Reactions And Medical Device Incidents
On June 10, 2019, the Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals)and Regulations Amending the Medical Devices Regulations
Canada
5 Aug 2019
2
Biosimilars No Longer Reviewed By CADTH
The Canadian Agency for Drugs and Technologies in Health (CADTH) released Issue 8 of its Pharmaceutical Reviews Update announcing updates
Canada
5 Aug 2019
3
Health Canada, TPD And BGTD Annual Reports Released
On June 27, 2019, Health Canada published Drug and medical device highlights 2018: Helping you maintain and improve your health, an annual highlights report for 2018.
Canada
5 Aug 2019
4
Biosimilars: Market Access, Naming, Studying Usage
As of June 30, Health Canada had approved 16 biosimilars, based on 11 comparator products (3 in 2019).
Canada
16 Jul 2019
5
Health Canada: Statutory And Regulatory Amendments, Medical Devices Updates, Court Decisions, Revised CSP Guidance
Food and Drugs Act amendments: Bill C-97, tabled in April, proposed amendments to the Food and Drugs Act, including a new framework for "Advanced Therapeutic Products"
Canada
16 Jul 2019
6
Medical Devices Update
On June 15, 2019, the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Post-market Surveillance of Medical Devices) (Regulations) were pre-published
Canada
10 Jul 2019
7
FCA Upholds Issuance Of NON-W Letter And Cancellation Of Reconsideration Process For Apotex Omeprazole Magnesium Tablet ANDS
On April 24, 2019, the Federal Court of Appeal (FCA) affirmed the Federal Court's (FC) dismissal of Apotex's application for judicial review of a decision
Canada
14 Jun 2019
8
Supreme Court Of Canada Denies Apotex Leave To Appeal Federal Court Of Appeal's Rejection Of Judicial Review Of Health Canada Decision Regarding India Facilities
As previously reported, the Federal Court of Appeal (FCA) dismissed Apotex's appeal of a judicial review decision of the Therapeutic Products Directorate (TPD) ...
Canada
15 Apr 2019
9
Health Canada Launches E-Learning Tool For Understanding Premarket Regulatory Requirements For Medical Devices
On March 19, 2019, Health Canada published a Notice, announcing the launch of its e-Learning tool: Understanding How Medical Devices are Regulated in Canada – Premarket Regulation.
Canada
15 Apr 2019
10
Final Regulations Addressing The Public Release Of Clinical Information Now In Force
On March 4, 2019, the final Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) and Regulations Amending the Medical Devices Regulations came into force.
Canada
15 Apr 2019
11
Health Canada Announces Further Steps On The "Action Plan On Medical Devices"
The SAC-HPW will provide advice on issues regarding women's health and regulation of medical devices and drugs.
Canada
7 Mar 2019
12
Abbott/Takeda Permitted To Plead That A Third Party's Patent Would Be Infringed By Alleged Non-Infringing Alternative
On the eve of a section 8 trial, the Ontario Superior Court granted Abbott and Takeda leave to amend their pleadings to assert that Apotex's purported non-infringing alternative (NIA)
Canada
5 Feb 2019
13
New Court Proceedings - January 2019
For complete details about these proceedings, click here.
Canada
5 Feb 2019
14
Health Canada Releases Medical Devices Action Plan
On December 20, 2018, Health Canada published an Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality.
Canada
5 Feb 2019
15
Under Reserve: Appeal From Judicial Review Quashing PMPRB Decision On Jurisdiction Over DIFFERIN
On January 17, 2019, the Federal Court of Appeal heard the Attorney General of Canada's appeal from a judicial review that quashed a Board decision that it has jurisdiction ...
Canada
5 Feb 2019
16
PMPRB Issues A Notice Of Hearing For Allegations Of Excessive Pricing Of PROCYSBI
The Board will hold a public hearing (on a date to be determined no later than February 27, 2019) to determine whether Horizon Therapeutics Canada is selling ...
Canada
5 Feb 2019
17
2018 Highlights In Canadian Life Sciences IP
In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: #1 a June update on biosimilars (authored by Urszula Wojtyra);
Canada
10 Jan 2019
18
New Court Proceedings - December 2018
For complete details about these proceedings, click here.
Canada
28 Dec 2018
19
FCA Overturns Cefaclor Damages Decision On Prejudgment Interest Issue, Provides Guidance On NIA Defence
On November 23, 2018, the Federal Court of Appeal (FCA) allowed in part Apotex's appeal of a decision awarding Eli Lilly over $100 million for Apotex's infringement of eight process patents ...
Canada
28 Dec 2018
20
CADTH Releases Environmental Scan On International Policies On Use Of Biosimilars
In October 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) issued an interesting Environmental Scan on International Policies on the Appropriate Use of Biosimilar Drugs (Report).
Canada
6 Dec 2018
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