Health Canada Revising Cosmetic/Drug Classification Policies

Health Canada is revising policies used to classify products that share characteristics of both cosmetics and drugs, (eg. acne treatments, toothpastes.) The policies will be applied in Fall 2007, and existing products may be re-classified then. A 30-day consultation period on these changes ended July 10th. To view a copy of the newly-released Guidance Document click here. To visit Health Canada's web page regarding these changes click here.

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Health Canada News Latest news provided by Health Canada	U.S. FDA News Latest news from the Food & Drug Administration
Health Canada Reminds Consumers That Some Ayurvedic Medicinal Products Contain High Levels of Heavy Metals 2008-05-08 Health Canada is reminding consumers who choose to use unapproved Ayurvedic medicinal products that some of these products may contain high levels of heavy metals. [ more ] Government of Canada Reaches Out to First Nations and Inuit Communities as Part of Anti-Drug Strategy 2008-05-08 The Honourable Tony Clement, Minister of Health, the Honourable Chuck Strahl, Minister of Indian and Northern Affairs, and the Honourable Rob Nicholson, Minister of Justice and Attorney General of Canada, today announced federal funding of $30.5 million over five years, under the National Anti-Drug Strategy, to bolster services across Canada that will help First Nations and Inuit who suffer from drug addictions. [ more ] Vpxl No1 Dietary Supplement for Men 2008-05-05 The Danish Medicines Agency advised consumers not to use the product Vpxl No1 Dietary Supplement for Men because it was found to contain tadalafil. Tadalafil is a prescription drug used for the treatment of erectile dysfunction that should only be taken under the guidance of a health professional. [ more ] Health Canada Advises Canadians to Limit Consumption of Lobster Tomalleys 2008-05-05 Health Canada advises Canadians to limit their consumption of lobster tomalleys because a toxin specific to lobster and shellfish, known as paralytic shellfish poison, can sometimes be found in these organs. [ more ] Government of Canada Helps P.E.I. to Cut Wait Times for Cancer Care 2008-05-02 The Honourable Tony Clement, Minister of Health and the Honourable Doug Currie, Minister of Health for Prince Edward Island today announced further developments in Patient Wait Times Guarantees with a total investment of $1.8 million for a pilot project in Prince Edward Island. [ more ] Health Canada Warns Consumers Not to Use Vigoureux or Any Unauthorized Products Promoted for Erectile Dysfunction 2008-04-25 Health Canada is warning consumers not to use Vigoureux, an unauthorized product promoted for the treatment of erectile dysfunction. [ more ] Canada's Food Guide Now Available in 10 Additional Languages 2008-04-25 The Honourable Tony Clement, Minister of Health, today announced that, for the first time in history, Eating Well with Canada's Food Guide is now available in 10 additional languages. [ more ] World Hemophilia Day - April 22, 2008 2008-04-22 April 22nd is World Hemophilia Day, a day devoted to bringing awareness to a disorder that affects people around the world. [ more ]	Drug Evaluation & Research BPCA/Pediatric Exclusivity Statistics Fri, 09 May 2008 15:00 EDT BPCA/Pediatric Exclusivity Statistics: Written Requests Issued and Pediatric Exclusivity Statistics (updated) [ more ] Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Fri, 09 May 2008 08:45 EDT Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) [ more ] Month First-Time Generic Drug Approvals Fri, 09 May 2008 07:45 EDT Office of Generic Drugs: First-Time Generic Drug Approvals [ more ] Paragraph IV Patent Certifications Thu, 08 May 2008 13:40 EDT Office of Generic Drugs: Paragraph IV Patent Certifications (updated) [ more ] Letters Thu, 08 May 2008 12:00 EDT Trileptal (Warning Letter) and Fosrenol Letters posted. [ more ] Drugs@FDA Downloadable Data Files (updated) Wed, 07 May 2008 14:40 EDT Drugs@FDA Downloadable Data Files (updated) [ more ] CDER Manual of Policies and Procedures (MaPPs) Tue, 06 May 2008 16:00 EDT Providing General Consumer Information on New Molecular Entities on CDER?s Web Site [ more ] The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter Tue, 06 May 2008 12:15 EDT The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter and attachments [ more ] BPCA/Pediatric Exclusivity Statistics: List of Determinations Including Written RequEDT (updated) Fri, 02 May 2008 17:55 EDT BPCA/Pediatric Exclusivity Statistics: List of Determinations Including Written RequEDT (updated) [ more ] Biologics Evaluation & Research User Fee Thu, 7 May 2008 15:38:17 EST Billable Products Approved Under Section 351 of the PHS Act [ more ] Violative Advertising and Promotional Labeling Letter Wed, 7 May 2008 13:34:00 EST Thrombin, Topical (Recombinant) (Recothrom) - ZymoGenetics, Inc [ more ] Licensed Products and Establishments List Wed, 7 May 2008 09:14:17 EST Update [ more ] Approved Biological NDA and ANDA Applications Tue, 6 May 2008 13:00:00 EST Update [ more ] Cleared Biological 510(k) Device Applications Tue, 6 May 2008 13:00:00 EST Update [ more ] Approved Biological Premarket Approval (PMA) Device Applications Tue, 6 May 2008 13:00:00 EST Update [ more ] Vacancy Announcement Tue, 6 May 2008 10:40:00 EST Consumer Safety Officer (CSO)/Lead CSO /Supv CSO [ more ] Vacancy Announcement Tue, 6 May 2008 10:40:00 EST Epidemiologist/Lead Epidemiologist/Supv Epidemiologist [ more ] Vacancy Announcement Tue, 6 May 2008 10:40:00 EST Pharmacologist /Lead Pharmacologist/Supv Pharmacologist [ more ] [Click for Other FDA News Sources]

Health Canada News

U.S. FDA News

Latest news from the Food & Drug Administration

Health Canada Reminds Consumers That Some Ayurvedic Medicinal Products Contain High Levels of Heavy Metals
2008-05-08
Health Canada is reminding consumers who choose to use unapproved Ayurvedic medicinal products that some of these products may contain high levels of heavy metals. [ more ]

Government of Canada Reaches Out to First Nations and Inuit Communities as Part of Anti-Drug Strategy
2008-05-08
The Honourable Tony Clement, Minister of Health, the Honourable Chuck Strahl, Minister of Indian and Northern Affairs, and the Honourable Rob Nicholson, Minister of Justice and Attorney General of Canada, today announced federal funding of $30.5 million over five years, under the National Anti-Drug Strategy, to bolster services across Canada that will help First Nations and Inuit who suffer from drug addictions. [ more ]

Vpxl No1 Dietary Supplement for Men
2008-05-05
The Danish Medicines Agency advised consumers not to use the product Vpxl No1 Dietary Supplement for Men because it was found to contain tadalafil. Tadalafil is a prescription drug used for the treatment of erectile dysfunction that should only be taken under the guidance of a health professional. [ more ]

Health Canada Advises Canadians to Limit Consumption of Lobster Tomalleys
2008-05-05
Health Canada advises Canadians to limit their consumption of lobster tomalleys because a toxin specific to lobster and shellfish, known as paralytic shellfish poison, can sometimes be found in these organs. [ more ]

Government of Canada Helps P.E.I. to Cut Wait Times for Cancer Care
2008-05-02
The Honourable Tony Clement, Minister of Health and the Honourable Doug Currie, Minister of Health for Prince Edward Island today announced further developments in Patient Wait Times Guarantees with a total investment of $1.8 million for a pilot project in Prince Edward Island. [ more ]

Health Canada Warns Consumers Not to Use Vigoureux or Any Unauthorized Products Promoted for Erectile Dysfunction
2008-04-25
Health Canada is warning consumers not to use Vigoureux, an unauthorized product promoted for the treatment of erectile dysfunction. [ more ]

Canada's Food Guide Now Available in 10 Additional Languages
2008-04-25
The Honourable Tony Clement, Minister of Health, today announced that, for the first time in history, Eating Well with Canada's Food Guide is now available in 10 additional languages. [ more ]

World Hemophilia Day - April 22, 2008
2008-04-22
April 22nd is World Hemophilia Day, a day devoted to bringing awareness to a disorder that affects people around the world. [ more ]

Drug Evaluation & Research

BPCA/Pediatric Exclusivity Statistics
Fri, 09 May 2008 15:00 EDT
BPCA/Pediatric Exclusivity Statistics: Written Requests Issued and Pediatric Exclusivity Statistics (updated) [ more ]

Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies
Fri, 09 May 2008 08:45 EDT
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) [ more ]

Month First-Time Generic Drug Approvals
Fri, 09 May 2008 07:45 EDT
Office of Generic Drugs: First-Time Generic Drug Approvals [ more ]

Paragraph IV Patent Certifications
Thu, 08 May 2008 13:40 EDT
Office of Generic Drugs: Paragraph IV Patent Certifications (updated) [ more ]

Letters
Thu, 08 May 2008 12:00 EDT
Trileptal (Warning Letter) and Fosrenol Letters posted. [ more ]

Drugs@FDA Downloadable Data Files (updated)
Wed, 07 May 2008 14:40 EDT
Drugs@FDA Downloadable Data Files (updated) [ more ]

CDER Manual of Policies and Procedures (MaPPs)
Tue, 06 May 2008 16:00 EDT
Providing General Consumer Information on New Molecular Entities on CDER?s Web Site [ more ]

The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter
Tue, 06 May 2008 12:15 EDT
The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter and attachments [ more ]

BPCA/Pediatric Exclusivity Statistics: List of Determinations Including Written RequEDT (updated)
Fri, 02 May 2008 17:55 EDT
BPCA/Pediatric Exclusivity Statistics: List of Determinations Including Written RequEDT (updated) [ more ]

Biologics Evaluation & Research

User Fee
Thu, 7 May 2008 15:38:17 EST
Billable Products Approved Under Section 351 of the PHS Act [ more ]

Violative Advertising and Promotional Labeling Letter
Wed, 7 May 2008 13:34:00 EST
Thrombin, Topical (Recombinant) (Recothrom) - ZymoGenetics, Inc [ more ]

Licensed Products and Establishments List
Wed, 7 May 2008 09:14:17 EST
Update [ more ]

Approved Biological NDA and ANDA Applications
Tue, 6 May 2008 13:00:00 EST
Update [ more ]

Cleared Biological 510(k) Device Applications
Tue, 6 May 2008 13:00:00 EST
Update [ more ]

Approved Biological Premarket Approval (PMA) Device Applications
Tue, 6 May 2008 13:00:00 EST
Update [ more ]

Vacancy Announcement
Tue, 6 May 2008 10:40:00 EST
Consumer Safety Officer (CSO)/Lead CSO /Supv CSO [ more ]

Vacancy Announcement
Tue, 6 May 2008 10:40:00 EST
Epidemiologist/Lead Epidemiologist/Supv Epidemiologist [ more ]

Vacancy Announcement
Tue, 6 May 2008 10:40:00 EST
Pharmacologist /Lead Pharmacologist/Supv Pharmacologist [ more ]

[Click for Other FDA News Sources]