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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Eileen McMahon ordered by Published Date Descending.
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1
Drug Price Cooling In Canada's Election Year: Release Of Final PMPRB Regulations
Final amendments to the Patented Medicines Regulations have been announced by the Government of Canada giving the Patented Medicine Prices Review Board
Canada
16 Aug 2019
2
Federal Court Of Appeal's Ruling On The Judicial Review Of PMPRB Decision On Differin
On June 28, the Federal Court of Appeal (FCA) affirmed the lower court's approach to patent review in determining whether the Patented Medicine Prices Review Board (PMPRB)
Canada
22 Jul 2019
3
PMPRB Decision Stands: Soliris Priced Excessively
The Federal Court has dismissed an application for judicial review by Alexion Pharmaceuticals Inc. (Alexion) in relation to a decision of the Patented Medicine Prices
Canada
8 Jul 2019
4
Simplifying Access To Unauthorized Drugs In Canada
The Canadian government has published proposed amendments to the Food and Drug Regulations (Regulations) that will improve access to unauthorized human drugs through the Special Access Program (SAP)
Canada
26 Jun 2019
5
2018 Year In Review: Top 10 Medical Device Regulatory Issues In Canada
A raft of changes to the Canadian medical device regulatory landscape were seen in 2018, several of which were directed at harmonizing Canada's approach to medical device regulation with those of other countries
Canada
5 Jun 2019
6
Public Access To Clinical Information On Drugs And Medical Devices Granted
New regulations have been enacted by Health Canada to satisfy its objective of making clinical information in drug submissions and medical device applications ...
Canada
11 Apr 2019
7
Let Them Eat Cannabis – With Restrictions!
On December 22, 2018, the Canadian Federal Government published proposed regulations that will expand the permitted format for products that contain or are derived from cannabis.
Canada
8 Jan 2019
8
Software As Medical Devices And Digital Health In Canada: What's Next?
Medical devices in Canada are regulated federally by Health Canada's Medical Devices Bureau of the Therapeutic Products Directorate and governed by Canada's Food and Drugs Act (Act) and Medical Device Regulations (Regulations).
Canada
8 Nov 2018
9
Ontario Proposes Regulation Under "Sunshine" Law
Ontario is currently seeking feedback on its newly released proposed regulation under the "sunshine" legislation, the Health Sector Payment Transparency Act, 2017 (HSPTA).
Canada
7 Mar 2018
10
Potential Change In Store For Regulating Disclosure Of Clinical Information
On December 9, the Government of Canada published proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations (Regulations).
Canada
20 Dec 2017
11
Rules Change For Veterinary Use Of Antimicrobials
Amendments to the Food and Drug Regulations regarding the use of antimicrobial drugs in animals will come into force beginning on November 13, 2017.
Canada
22 Sep 2017
12
Government Of Canada Successful In Eli Lilly's NAFTA Challenge On The Promise Of The Patent Doctrine
On March 16, 2017, an arbitral tribunal appointed pursuant to the NAFTA, released its final decision in favour of the Government of Canada regarding Eli Lilly's case against the "promise utility doctrine."
Canada
4 May 2017
13
Federal Court Considers Patent Listing For Combination Drug Products
The Federal Court upheld two rulings of a prothonotary, both regarding listing of patents on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations.
Canada
21 Oct 2014
14
Data Protection: Sanofi Gains Standing In Hospira’s Objection To Application Of Data Protection
The Federal Court of Canada granted standing to Sanofi-Aventis Canada Inc. in a case involving a Sanofi product on the Register of Innovative Drugs.
Canada
9 Jun 2014
15
The CADTH Releases Submission Guidelines For Biosimilars
The Canadian Agency for Drugs and Technologies in Health released Common Drug Review Procedure and Submission Guidelines for Subsequent Entry Biologics.
Canada
3 Apr 2014
16
Considerations For Medical Device Software Companies Entering The Canadian Market
Canada has one of the world’s largest medical device markets, estimated at C$6 billion in 2010, with sales of almost C$3 billion taking place in Ontario. he medical device industry in Canada, not taking into account medical imaging and assistive devices, employs over 35,000 people in about 1,500 companies, the bulk of which are small or medium-sized companies.
Canada
27 Jul 2011
17
Six Rules For Wooing Investors
Biotech companies must compete for funding against other biotech firms and start-ups in other sectors.
Canada
26 May 2011
18
Classify Patient Management Software in Canada
Health Canada has Clarified the approach taken by its Medical Devices Bureau to Classify Patient Management Software as Either A Class I Or A Class II Medical Device
Canada
21 Jun 2010
19
Classifying Medical Device Software In Canada
Health Canada has indicated that it plans to release an updated notice on classifying patient management software in the coming weeks, modifying the notice it released on August 31, 2009.
Canada
18 Mar 2010
20
Health Canada Releases Final Guidance On Subsequent Entry Biologics
Health Canada has released the final version of its guidance document Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) (Final Guidance), which is an update of the draft guidance released by Health Canada on January 30, 2008 and March 27, 2009 and applies to all pending and future drug submissions for SEBs in Canada.
Canada
17 Mar 2010
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