Stewart Eisenhart, of Massdevice.com, reported that the China Food & Drug Administration (CFDA) is moving forward with improvements to their classification of medical devices process and is simplifying the road to the market for innovative devices. China has a three point plan to finish this project. First, create an online medium for medical device manufacturers to request regulatory validation of their product classification if they are unsure of its classification. In the past, it was purely a written process. Second, there will now be exemptions to the China Compulsory Certification (CCC) Mark certification that applies more to automotive, wireless, and consumer products. There will be only eight categories that will be exempt from the CCC. Finally, according to China Briefing, a new approval process can push new innovative devices into the market much quicker by having special circumstances and priority status to the review board. Will China be at risk with a less stringent path to market for innovative devices? Read the full article here.
New prescription drug supply chain requirements pass congressional committee
On Thursday, May 16th, Zachary Brennan reported, on in-PharmaTechnologist.com, that the bill H.R. 1919 has advanced passed the US House Energy & Commerce Committee. The bill, written by Rep. Bob Latta promises to further secure the US prescription drug supply chain and will now move to a full House of Representatives debate. Joe Pitts, Health Subcommittee Chairman and supporter of H.R. 1919, commented by saying, “Securing the supply chain through this bill will help insure that counterfeit or stolen drugs do not enter the supply chain and harm patients.” The bill sets requirements in milestones for what must be done by two, five, and seven years in the future. Within two years the Department of Health and Human Services (HHS) must create one or more pilot projects to evaluate the safety and security of the pharmaceutical supply chain. In five years, manufacturers must provide transaction history and have an identifier on any prescription drug that has intent to be sold. In seven years, wholesale drug distributors will only be allowed to sell if every package has been encoded to the bill’s description. To read the full article click here.
Canada joins other countries with strong GMP requirements for APIs
In-PharmaTecnologist.com’s Zach Brennan wrote a recent article about Canada’s agreement to strengthen the GMP requirements on active pharmaceutical ingredients (API). Canada is one of the last industrialized countries to extend GMP requirements on APIs but in doing so it will enhance the traceability of APIs throughout the supply chain process, decrease the amount of product recalls, and provide more serviceable products to Canadians. The new regulations will take effect in November of 2013 and the country’s drug establishment license requirements will then apply to API manufacturers, packagers/labelers, testers, and importers. Also, extending the GMP requirements on APIs will act as protection from poor quality drug products for Canadians. The transition process will be tough for some manufacturers but the government will let them do business without an establishment license as long as they have applied for one by February of 2014. For more details and the full article click here.
St. Vincent Health Research Symposium to be held June 12th at the Marten House
The St. Vincent Research and Regulatory Affairs will be hosting the 9th Annual St. Vincent Health Research Symposium next month. This daylong event will feature keynote speakers, William Droegemueller, MD, Distinguished Clinical Professor, Obstetrics and Gynecology at University of Colorado Medical School and Delia Wolf, MD, JD, MSCI, Assistant Dean, Regulatory Affairs & Research Compliance Director, Human Research Administration at Harvard School of Public Health.
The symposium will include both scientific and regulatory educational opportunities, and will highlight the Symposium Abstract Competition winners.
Fee: No fee for St. Vincent associates and Ascension associates. There is a $95.00 fee for general public.
When: Wednesday, June 12, 2013
Time: 7:00 AM – 5:00 PM (Continental breakfast and lunch included)
Where: Lilly Conference Center at the Marten House
1801 W 86th St., Indianapolis, IN 46260
For more information call (317) 388-2194 and to register click here
First quarter medical deal declines may not reflect the state of the M&A industry
In a recent article on massdevice.com, Brad Perriello shares interesting data from Pricewaterhouse Coopers’ (PWC) US Pharmaceutical and Life Sciences Deals Insights Quarterly report Medical device mergers and acquisition deals in the first quarter fell from eight in the Q1 of 2012 to seven in Q1 of 2013. The same time comparison had the total value dropping from $2.3 billion down to $1.7 billion. Dimitri Drone from PWC purports that this decline is not necessarily reflected of the true deal activity. Active and not yet closed deals are not included in these numbers and Drone says “There’s a lot of talk about M&A among the people we interact with in medical devices.” The report still forecasts a growth overall in medical device M&A activity for 2013. What do you think? Are you seeing more of an appetite for deals? To review the PWC report, click here, and for the full article click here.
IHIF May Lunch Series Addresses Crowdfunding
The IHIF May lunch series features Dr. Samuel P. Wertheimer, managing director at Poliwogg, an online marketplace for early investments, and Marcus Chandler, partner and Barnes & Thornburg LLP. They will be sharing professional insight about the budding crowdfunding investment strategy. The focus will be discussing legal, accounting, and business strategies specifically for bioscience commercialization projects.
Topic: “Crowdfunding for the Life Sciences”
When: Tuesday, May 21,2013
Registration: 11:30 – 12:00 PM
Presentation: 12:00 – 1:00 PM
Location: Barnes and Thornburg LLP, 11 S. Meridian St., Indianapolis, IN
For more information and registration click here.
For other information about bioscience startups visit Pearlpathways.com or call (317) 899-9341
FDA launches new website for patients
On April 23, 2013, the FDA launched a new website, FDA’s Patient Network. According to Margaret Hamburg, FDA Commissioner, the website is anticipated to “increase patient’s interest and participation in the agency’s work and in the policies and decisions that affect them.” The website was designed to make regulations clear to everyone and presents several categories from how to get in touch with FDA regulators to how to become informed about drug and device regulatory processes. The FDA hopes that the website will increase public involvement and open new lines of communication between the agency and the public. To read more on RAPS.org, click here.
FDA releases final guidance on Classification Product Codes
The FDA released final guidance entitled “Medical Device Classification Product Codes” which helps guide the medical device industry on how to use the Classification Product Codes (CPC). The FDA uses the CPC system to keep track of devices and maintain “quality and reliable” data for each device that is used for regulatory analysis. To read more about the code on RAPS.org, click here.
The FDA released final guidance entitled “Medical Device Classification Product Codes” which helps guide the medical device industry on how to use the Classification Product Codes (CPC). The FDA uses the CPC system to keep track of devices and maintain “quality and reliable” data for each device that is used for regulatory analysis. To read more about the code on RAPS.org, click here.
New study finds that physicians contribute to discovery of new medical devices
A recent study published in the May issue of Medical Care found that medical device startup companies founded by physicians developed roughly the same number of patents as non-physician founded startups. The study, conducted by Drs. Sheryl Winston Smith, PhD and Andrew Sfekas, PhD of the Fox School of Business at Temple University, focused on high-risk, class III medical devices which require substantial testing to prove safety and effectiveness. The study used an algorithm to examine the overlap between premarket approval applications and patents, which is important for identifying which patents are more important for developing new ideas. However, the researchers indicated that conflict of interest policies may result in fewer startups, if regulations are too tight. To read the full article on EurekAlert.org, click here.
Pearl partners with Hoosiers Work for Health
Pearl Pathways has partnered with the Hoosiers Work for Health coalition. Hoosiers Work for Health is the Indiana chapter of a national initiative that unites health consumers, biopharmaceutical company employees, vendors, suppliers and other business and community partners to showcase the importance of the life sciences industry on the Indiana economy and on the quality of health for Hoosiers. Partners include local chambers of commerce and research centers, labor, businesses, patient advocacy organizations, provider groups and biopharmaceutical research companies that work together to improve America’s health care system and strengthen our economy. For more information, visit www.hoosiersworkforhealth.org
