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Searching Content indexed under Food and Drugs Law by Smart & Biggar ordered by Published Date Descending.
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1
Canada Releases Final Amendments To Patented Medicines Pricing Regulations; In Force July 1, 2020
There are a number of notable changes to the regulations relative to the draft version published December 2, 2017.
Canada
26 Sep 2019
2
Countdown To July 1, 2020: Getting Ready For The New Patented Medicines Pricing Regime
The amended Regulations will come into force on July 1, 2020.
Canada
26 Sep 2019
3
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
4
Federal Court Of Appeal Dismisses First PMNOC Interlocutory Appeal Granted Leave
Most interlocutory decisions under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) are made by prothonotaries of the Federal Court (FC).
Canada
5 Aug 2019
5
Court Strikes Novo Nordisk's Judicial Review Application Of Minister's Acceptance Of Teva's Liraglutide ANDS
The Federal Court struck Novo Nordisk's judicial review application challenging the decision of the Minister of Health to accept for review an Abbreviated New Drug Submission (ANDS)
Canada
5 Aug 2019
6
PMPRB Steering Committee On Modernization Of Price Review Process Guidelines Releases Final Report
On July 2, 2019, the PMPRB Steering Committee on the Modernization of Price Review Process Guidelines released its final report summarizing
Canada
5 Aug 2019
7
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
8
Guidance Updates
Health Canada released a revised Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs on June 28, 2019
Canada
5 Aug 2019
9
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
10
Bill C-97 Receives Royal Assent, Advanced Therapeutic Products Consultation Opened
On June 21, 2019, Bill C-97 received Royal Assent. Bill C-97 includes amendments to the Food and Drugs Act, including a new framework for "Advanced Therapeutic Products"
Canada
5 Aug 2019
11
Federal Court Of Appeal Requires PMPRB To Re-Determine Whether Patent ‘Pertains To' Galderma's DIFFERIN
On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB or Board) and returned to the Board the matter of whether the invention of the 237
Canada
5 Aug 2019
12
Pre-Amended PMNOC Regulations: Court Decisions On The Merits (Polymorph, Salt, Formulation Patents)
There have been two Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) decisions on the merits so far in 2019 and a pair of appeal decisions
Canada
16 Jul 2019
13
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
14
Market Access: National Pharmacare, OHIP+, Costco Rebates
On June 12, the Advisory Council on the Implementation of National Pharmacare released its final report which recommends that Canada implement a universa
Canada
16 Jul 2019
15
PMPRB News: Amendments Still Not Released; Alexion/SOLIRIS, Galderma/DIFFERIN Decisions
While originally proposed to come into force on January 1, 2019, sweeping amendments to the Patented Medicines Regulations governing pricing criteria were still not released as of June 30
Canada
16 Jul 2019
16
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
17
CADTH Reports On Integration Of CDIAC Functions Into pCODR Process
On June 12, 2019, the Canadian Agency for Drugs and Technologies in Health (CADTH) reported changes (effective July 1, 2019) to transition Cancer Drug Implementation
Canada
10 Jul 2019
18
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
19
New PMPRB Report Examines Most Promising Medicines Currently In Clinical Trials Worldwide
On May 30, 2019, the PMPRB published the 2018 edition of the Meds Pipeline Monitor, a horizon scanning report which provides a snapshot of the new drug landscape
Canada
10 Jul 2019
20
Federal Court Upholds PMPRB's Pricing Decision Regarding Alexion's SOLIRIS
On June 12, 2019, Justice Gleeson dismissed Alexion's application for judicial review of a Panel of the Patented Medicines Price Review Board (PMPRB)'s (i) decision
Canada
10 Jul 2019
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