Golden Bull - would you please help me on Health Canada approval?
I found the following article while checking around re the FDA approval process for BIEL: site name www.outrageousbus.com
Advances in Bioelectronics FDA approvals
Posted on December 18, 2011 by admin
Bioelectronics described its existing counter, and the renewed application of products:In addition, the company plans to introduce a new product 510 (k) application for approval of an alternative over-the-counter products for temporary relief of pain associated with muscle aches and pains. Equivalent Korean ActiPatch recently approved by the FDA for the treatment of muscle pain.
A request for new wound care products will help treat post-operative pain and edema. This indication of the wider use of tags allows all medical specialties, including specialists in chronic wounds, to prescribe products with RecoveryRx trust.
In order to remove its products from menstrual pain relief, bioelectronics formally requested the change in its application from a 510 (k) of section 513 (f) (2) a review de novo. The request for classification is supported by further research and clinical evidence demonstrating the efficacy of treatments such as electronic medical therapy effective for dysmenorrhea. Last week, Health Canada issued a license to market the therapy to ease menstrual pain in Canada.
Bioelectronics Corporation (PINKSHEETS: BIEL), developers of innovative topical pain medical care, has announced it is strengthening its applications in the United States with the FDA and the results of further research to better articulate its classification of products, and to improve claims his pain patented products.
The application produces ActiPatch 510 (k) for the treatment of musculoskeletal pain is still being reviewed by the FDA. Bioelectronics Research provides the FDA and additional documents in support of this authorization.
Two new product applications, FDA will significantly expand this product line. RecoveryRx products are currently approved by the FDA U. S. only for the treatment of the following blepharoplasty, hampering U.S. sales and marketing for the medical specialties other than plastic surgeons.
“The FDA approval process is long and difficult, especially for unique products and innovative, but we are confident that our results of further research and product options, we’ll succeed,” said Andrew Whelan, President and CEO of bioelectronics . “We intend to provide such data to the FDA in the United States to complete applications and obtain additional markets for our new residence. After all, we have already sold over 200,000 units through the world safely and effectively.END
Golden Bull - can you please help me understand why Health Canada, presumably the FDA for Canada, approved the BIEL product Allay for menstrual pain ahead of the FDA here? I thought the US was trying to regain the leading edge on innovative products after the Japanese economy collapsed. What gives? Thanks very much
