Health Canada Harper Government Announces Passage of Vanessa's Law - Modernized Laws for Drugs and Medical Devices Mark a New Era in Canadian Patient Safety...
The Honourable Rona Ambrose, Minister of Health, joined by Member of
Parliament for Oakville Terence Young, today celebrated a major
milestone for patient safety in Canada - the passage of new legislation
known as Vanessa’s Law (the Protecting Canadians from Unsafe Drugs Act).
Delivering on a promise in the 2013 Speech from the Throne, the Act
will protect Canadians from unsafe medicine by enabling the Government
to:
- Recall unsafe products;
- Impose tough new penalties for unsafe products, including jail time and new fines of up to $5 million per day instead of the current $5,000;
- Provide the courts with discretion to impose even stronger fines if violations were caused intentionally;
- Compel drug companies to revise labels to clearly reflect health risk information in plain language, including updates for health warnings for children;
- Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children;
- Enhance surveillance by requiring mandatory adverse drug reaction reporting by healthcare institutions;
- Require new transparency for Health Canada’s regulatory decisions about drug authorizations, both positive and negative;
- Require information about authorized Canadian clinical trials to be posted on a public registry;
- Better define confidential business information and disclose such information about a product if it may pose a serious risk to Canadians.
These new transparency measures build on the progress Health Canada has already achieved through its Regulatory Transparency and Openness Framework.
The Framework commits Health Canada to a set of concrete initiatives
that will make easy-to-understand regulatory health and safety
information more available to Canadians.
Quick Facts
- Vanessa's Law is named after Member of Parliament Terence Young’s daughter Vanessa, who died of a heart attack while on a prescription drug that later was deemed not safe and removed from the market.
- The Bill received all-party support in the House of Commons in light of its important new safety provisions that will benefit Canadians.
- The Protecting Canadians from Unsafe Drugs Act introduces the most profound and important changes to the Food and Drugs Act that have been made since it was introduced more than 50 years ago.
Quotes
“Today is an historic day for patient safety in Canada. As Minister
of Health, nothing is more important to me than the safety of Canadians
and their families. Through Vanessa’s Law, Canadians will be better
informed about medications they are prescribed, and our Government will
be empowered to recall unsafe products from the market. I am confident
that Canadians will be better protected and lives will be saved as a
result of these changes.” Rona Ambrose, Minister of Health
For more details CLICK HERE
USFDA approved Ramucirumab in combination with paclitaxel...
On November 5, 2014, the U. S. Food and Drug Administration approved
ramucirumab (Cyramza, Eli Lilly and Company) for use in combination with
paclitaxel for the treatment of patients with advanced gastric or
gastroesophageal junction (GEJ) adenocarcinoma. Ramucirumab was
approved in April, 2014 as a single agent for the treatment of patients
with advanced gastric or GEJ adenocarcinoma refractory to or progressive
following first-line therapy with platinum or fluoropyrimidine
chemotherapy.
For more details on approval please CLICK HERE
USFDA: New and Generic Drug Approvals: 03 NOV 2014
New and Generic Drug Approvals
November 3, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Desonide | desonide | Lotion;Topical | Taro | Approval |
| Furadantin | nitrofurantoin | Suspension;Oral | Shionogi Inc | Manufacturing Change or Addition |
| Kyprolis | carfilzomib | Powder;Intravenous | Onyx Pharms | Manufacturing Change or Addition |
| Lamivudine | lamivudine | Solution;Oral | Silarx Pharms Inc | Approval |
| Levitra | vardenafil hydrochloride | Tablet;Oral | Bayer Hlthcare | Manufacturing Change or Addition |
| Lunesta | eszopiclone | Tablet;Oral | Sunovion Pharms Inc | Manufacturing Change or Addition |
| Marqibo Kit | vincristine sulfate | Injectable, Liposomal;Intravenous | Talon Therap | Manufacturing Change or Addition |
| Northera | droxidopa | Capsule;Oral | Lundbeck Na Ltd | Manufacturing Change or Addition |
USFDA CDRH MEDICAL DEVICES WEBINARS : Download CDRH Industry Basics Workshop (All Day Webinars) – November 4, 2014
Date: 5th Nov 2014
Webinar: CDRH Industry Basics Workshop
Summary: This workshop (presented by webinar) will provide information on the fundamental concepts of medical device regulations.
The workshop will feature five sessions, each of which will consist
of a presentation followed by a question and answer session with a panel
of experts. Participants will be able to email or call us with your
questions during each session.
Participants can choose to participate in any and/or all of the
sessions. Each session will begin precisely at the scheduled time. Click link to view.download printable slides of respective webinar
- 10:00-11:00 am: Investigational Device Exemption (IDE) Program
- 11:00-12:00 noon: 510(k) Program
- 12:00-1:00 pm: De Novo Program
- 2:00-3:00 pm: Corrective and Preventive Actions (CAPA) Basics
- 3:00-4:00 pm: Electronic Medical Device Reporting (eMDR) 21 CFR Part 803
Target Audience included experts and professionals from Medical Device Industry, Medical Device Developers, Medical Device Industry Associations.
USFDA: New and Generic Drug Approvals: 31 OCT 2014
New and Generic Drug Approvals
October 31, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Lexapro | escitalopram oxalate | Tablet;Oral | Forest Labs | Labeling Revision |
| Lexapro | escitalopram oxalate | Solution;Oral | Forest Labs | Labeling Revision |
| Nuvaring | ethinyl estradiol; etonogestrel | Ring;Vaginal | Organon Usa Inc | Labeling Revision |
| Treprostinil | treprostinil | Injectable;Injection | Sandoz Inc | Tentative Approval |
USFDA CDRH Webinar on Distinguishing Medical Device Recalls from Medical Device Enhancements conducted on 5th Nov 2014..
Webinar: Distinguishing Medical Device Recalls from Medical Device Enhancements – Final Guidance
Summary: The
guidance clarifies for manufacturers how to determine when changes to a
device constitute a recall and when they are considered a product
enhancement.
The guidance contains clear definitions and practical
examples to help manufacturers distinguish a recall from an
enhancement. Correctly identifying a change to a device as a recall
reduces the time between identification of a device defect/failure and
public notification.
Clarifying when a change to a device
represents a recall or an enhancement will help manufacturers better
understand when reporting device changes to the FDA is required.
View/Download Printable Slides of the Webinar CLICK HERE
MHRA Medicine Recall Alert : Zovirax Eye Ointment manufactured by The Welcome Foundation Limited trading as GlaxoSmithKline UK
Class 2 medicines recall
Action Within 48 Hours
Pharmacy and Wholesaler Level Recall
The Welcome Foundation Limited trading as GlaxoSmithKline UK
Zovirax Eye Ointment (Aciclovir 3%)
PL 0003/0150
Batch No.: 3L942 (Exp. Date Oct 2018, Pack Size: 4.5G, First Distributed 10JAN2014)
Batch No.: 3M941 (Exp. Date Jan 2019, Pack Size: 4.5G, First Distributed 07APR2014)
GlaxoSmithKline UK is recalling the below mentioned batches of Zovirax Eye
Ointment as a precaution because the batches of pharmaceutical
ingredient used in their manufacture were found to contain metal
particles which were outside the upper specification limit for particle
size. No complaints or adverse reaction reports relating to this issue
have been received by the company to date.
Remaining stocks of the above batches should be quarantined and returned to the original supplier for credit. For enquiries relating to stock return please contact your original supplier.
There are no alternative batches of this product currently available and we understand that shortages are already being reported. Please find attached a copy of a Memo from UK Medical information (UKMI)
advising on the availability of alternative therapies for the treatment of herpes simplex keratitis.
For more details CLICK HERE
MHRA Press Release : Professor Sir Michael Rawlins appointed Chair of MHRA
The MHRA announced
the appointment of Professor Sir Michael Rawlins as its new Chair. He
will take charge from 01 Dec 2014 for 3 years.
Professor Sir Michael will take over from Sir Gordon Duff who announced
his intention to step down earlier this year, following his election as
Principal of St Hilda’s College, Oxford.
Professor Sir Michael Rawlins was until recently Chair of the National Institute of Health & Clinical Excellence (NICE), a role from which he stood down in 2013. He is also currently Chairman of Biobank.
For details CLICK HERE
USFDA: New and Generic Drug Approvals: 30 OCT 2014
New and Generic Drug Approvals
October 30, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Ammonia N 13 | ammonia n 13 | Injectable;Injection | The Brigham and Women's Hospital Inc | Approval |
| Bystolic | nebivolol hydrochloride | Tablet;Oral | Forest Labs | Manufacturing Change or Addition |
| Celecoxib | celecoxib | Capsule;Oral | Lupin Ltd | Approval |
| Diflucan | fluconazole | Tablet;Oral | Pfizer | Labeling Revision |
| Diflucan | fluconazole | For Suspension;Oral | Pfizer | Labeling Revision |
| Docefrez | docetaxel | Injectable;Injection | Sun Pharma Global | Labeling Revision |
| Envarsus Xr | tacrolimus | Tablet, Extended Release;Oral | Veloxis Pharma Inc | Tentative Approval |
| Fludeoxyglucose F18 | fludeoxyglucose f18 | Injectable;Injection | The Brigham and Women's Hospital Inc | Approval |
| Fludeoxyglucose F18 | fludeoxyglucose f18 | Injectable;Injection | Hot Shots Nm Llc | Approval |
| Humulin R | insulin recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin R Pen | insulin recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Imatinib Mesylate | imatinib mesylate | Tablet;Oral | Apotex Inc | Tentative Approval |
| Lamotrigine | lamotrigine | Tablet, Orally Disintegrating;Oral | Par Pharm Inc | Tentative Approval |
| Locoid | hydrocortisone butyrate | Cream;Topical | Precision Dermat | Labeling Revision |
| Locoid | hydrocortisone butyrate | Ointment;Topical | Precision Dermat | Labeling Revision |
| Locoid | hydrocortisone butyrate | Solution;Topical | Precision Dermat | Labeling Revision |
| Locoid | hydrocortisone butyrate | Lotion;Topical | Precision Dermat | Labeling Revision |
| Lopressor | metoprolol tartrate | Tablet;Oral | Us Pharms Holdings I | Manufacturing Change or Addition |
| Montelukast Sodium | montelukast sodium | Tablet;Oral | Unimark Remedies Ltd | Approval |
| Montelukast Sodium | montelukast sodium | Tablet, Chewable;Oral | Unimark Remedies Ltd | Approval |
| Mycophenolic Acid | mycophenolic acid | Tablet, Delayed Release;Oral | Teva Pharms Usa | Approval |
| Nascobal | cyanocobalamin | Spray, Metered;Nasal | Par Pharm | Manufacturing Change or Addition |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | norethindrone acetate;ethinyl estradiol ferrous fumarate | Tablet;Oral | Famy Care Ltd | Approval |
| Nutrestore | glutamine | For Solution;Oral | Emmaus Medcl | Manufacturing Change or Addition |
| Omtryg | omega-3-acid ethyl esters | Capsule;Oral | Trygg | Manufacturing Change or Addition |
| Orfadin | nitisinone | Capsule;Oral | Swedish Orphan | Manufacturing Change or Addition |
| Symbyax | fluoxetine hydrochloride; olanzapine | Capsule;Oral | Lilly | Manufacturing Change or Addition |
| Vyvanse | lisdexamfetamine dimesylate | Capsule;Oral | Shire Development | Manufacturing Change or Addition |
| Zavesca | miglustat | Capsule;Oral | Actelion Pharms Ltd | Manufacturing Change or Addition |
| Zykadia | ceritinib | Capsule;Oral | Novartis Pharms Corp | Manufacturing Change or Addition |
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