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FDA announces that Plan B morning-after birth control may be sold over-the-counter to women and men aged 17 and younger. This follows a federal judge’s decision in March 2009 that orders the agency to make the drug available to minors.
FDA schedules an internal meeting to discuss the next steps for handling device controversies within CDRH. Donna-Bea Tillman, director of the Office of Device Evaluation, sent an e-mail two weeks prior announcing an “all-hands meeting” to discuss the strategic direction of the device center. Two unnamed FDA officials say that such a broad meeting of ODE staff—including all scientists within the office—has not been held for years.
Changes in the code emphasize increased restrictions on promotional items and gifts. They also include clarified guidelines for conduct for entering into royalty arrangements and introduce parameters for providing products for educative purposes.
http://advamed.org/NR/rdonlyres/61D30455-F7E9-4081-B219-12D6CE347585/0/AdvaMedCodeofEthicsRevisedandRestatedEffective20090701.pdf
The collapse of Lehman Brothers puts thousands of people out of work worldwide. The investment bank is one of the first major casualties of the global credit crisis. Also in September, the securities firm Merrill Lynch agrees to sell itself to Bank of America and the government takes control of mortgage finance companies Fannie Mae and Freddie Mac. The economic downfall is partially attributed to subprime mortgages.
Norman Noble, Inc. expands facilities with major expansion of its Orthopedic Implant Manufacturing Operations.
http://www.nnoble.com
In the United States, the national average price for a gallon of regular gasoline rises to an all-time high of $4.11. Diesel costs $4.85 per gallon. The high prices are partially driven by growing demand in developing nations such as China and India.
The world’s first airway transplant is performed at the Hospital Clinic at the University of Barcelona. Doctors replace a section of Claudia Castillo’s windpipe using a donated organ that is partially grown from stem cells from Castillo’s own bone marrow.
In the United States, cases of the Salmonella St. Paul strain are first reported. The outbreak is linked to tomatoes, Serrano and jalapeño peppers, and cilantro, which forces restaurants to remove many items from their menus. The strain sickens 1442 persons, two of whom die.
FDA announces that the contamination of blood thinner Heparin may have been intentional. The agency says that an active pharmaceutical ingredient was substituted in the drug during the manufacturing process in China, which led to more than 80 deaths. Some medical devices are also affected by the contamination.
Plastics One, Inc., medical component design and manufacturer with 60 years in business, announces the completion of a 15,000 sq. ft. addition, bringing the facility to 80.000 sq. ft.
http://www.plastics1.com/Tour.php
IW MinVasive introduced thin-walled PTFE line polyimide and Pebax tubing
http://www.minvasivecomponents.com
MD&DI starts to include in every issue an online table of contents, which features information about online exclusives, videos, and extended articles.
At the Henri-Mondor Hospital in France, Pascal Coler receives what is considered the world’s first full face transplant. Toward the end of the year, the first face transplant in the United States is performed on Connie Culp at the Cleveland Clinic.
Professional baseball is turned on its head with the release of the Mitchell Report, a 409-page investigational report from former senator George Mitchell that details the use of illegal performance-enhancing substances by players. The report names 89 MLB players who have allegedly used steroids or drugs.
Five orthopedic companies settle with the U.S. Department of Justice over allegations that they may have paid kickbacks to surgeons in return for favoring their hip and knee implants. The five are Biomet, Johnson & Johnson’s Depuy Orthopedics, Smith & Nephew, Stryker, and Zimmer. Four of the firms, excluding Stryker, pay a combined $311 million to settle the claims.
http://www.devicelink.com/mddi/blog/?p=491
CDRH announces that two pathways for submitting electronic medical device reports (MDRs) are available: CeSub (low volume) and HL7 (high volume).
http://www.devicelink.com/mddi/archive/07/07/014.html
Apple announces the sale of the 100,000,000th iPod, making the iconic device the fastest-selling music player in history.
FDA unveils a site that shows the status of postapproval patient studies for certain recently approved medical devices.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm
Former FDA commissioner Lester Crawford is sentenced to three years of supervised probation and fined $90,000. He had previously pled guilty to conflict of interest and false reporting of information about stocks he owned in companies that he was in charge of regulating.
Eli Lilly debuts the first insulin pen with a memory chip. It features a digital display that allows patients to record and review their last 16 insulin doses.
FDA and the Veterans Health Administration (VHA) sign an agreement to share information and expertise related to the review and use of FDA-regulated medical products. The partnership is part of FDA’s ongoing drug and medical product safety initiatives.
http://www.fda.gov/oc/mous/domestic/225-07-4300.html
President Bush signs an executive order that makes it harder for federal agencies to issue policy guidances. Critics say the guidances are back-door attempts to impose regulations.
FDA lifts its 14-year ban on silicone gel breast implants.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01512.html
FDA approves the Merck’s cervical cancer vaccine Gardasil. It is the first vaccine developed to prevent cervical cancer, genital warts, and precancerous genital lesions from certain strains of HPV, the human papillomavirus. The agency calls it a “major advancement” in protecting public health.
http://www.fda.gov/bbs/topics/news/2006/new01385.html
FDA and the CDC investigate reports of fungal keratitis infections in contact lens wearers, which leads to Bausch & Lomb’s permanent removal of its ReNu with MoistureLoc products.
http://www.fda.gov/cdrh/safety/041006-keratitis.html
Surgeons in France perform the world's first face transplant, although not of a whole face. A 38-year-old woman severely disfigured by a dog attack receives a partial triangular graft, consisting of the chin, lips, and nose from a deceased female donor.
Avian influenza (H5N1) pandemic is considered a global threat. On September 29, 2005, David Nabarro, the newly appointed Senior United Nations System Coordinator for Avian and Human Influenza, warns the world that an outbreak of avian influenza could kill 5 to 150 million people.
The Senate confirms Lester M. Crawford as FDA commissioner by a vote of 78–16 after a long delay due to controversy over a review of a morning-after contraceptive pill. Crawford resigns two months later amid accusations of a conflict of interest and false reporting of information about stocks he owned in food, beverage, and medical device companies.
Researchers in Michigan develop a robot with a sense of touch. They plan to use the device to perform remote breast examinations. Photo courtesy of Kurt Stepnitz, Michigan State University.
MD&DI names the top 10 technologies in medical devices based on reader polls.
Norman Noble, Inc. opens its 3rd facility which provides 120,000 sq. ft. of additional manufacturing space for medical implants and devices.
http://www.nnoble.com
www.medtech-grp.com/Site/ID/10-17-2006.html
http://www.medtech-grp.com/Site/ID/10-17-2006.html
The medical device industry is well known for its technology, a central aspect that MD&DI covers in each and every issue. Less often noted are the many outstanding people without whom that technology would not exist. In this issue, MD&DI pays special tribute to 100 of these individuals.
http://www.devicelink.com/mddi/archive/04/06/004.html
David W. Feigal Jr., who has led the center since 1999; oversaw a major restructuring that included the implementation of user fees, more outreach to outside experts, and expanded educational programs for CDRH staff; steps down.
http://www.devicelink.com/mddi/archive/04/05/013.html
Lester Crawford, DVM, the current FDA deputy commissioner, becomes the agency's acting commissioner. Crawford has served as deputy commissioner since McClellan's appointment.
http://www.fda.gov/oc/crawford/bio.html
President Bush nominates FDA commissioner Mark B. McClellan, MD, PhD, to become the next administrator of the Centers for Medicare and Medicaid Services.
http://www.fda.gov/oc/commissioners/mcclellan.html
FDA amends its regulations and requires that the content of labeling be submitted to FDA electronically for new drug applications, abbreviated drug applications, certain biologics license applications, and annual reports.
President Bush signs the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003. The act expands the Medicare benefit package to include coverage for outpatient prescription drugs, creates health savings accounts, and increases payments to Medicare HMOs. Image Caption: President Bush signs the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 at Constitution Hall in Washington DC.
The magazine introduces a redesign in 2003, as well as the first Guide to Outsourcing supplement in March.
www.medtech-grp.com/Site/ID/StapleFormingCustomAutomation.html
http://www.medtech-grp.com/Site/ID/StapleFormingCustomAutomation.html
Before drug-eluting stents (DES) were approved by FDA, the Centers for Medicare and Medicaid Services takes the unprecedented step of providing for their reimbursement. As a result, the reimbursement code for Cordis Corp.’s Cypher stent goes into effect the same day that FDA approves the product. Image caption: The Cypher stent is the first drug-eluting stent for patients with coronary heart disease.
America begins its war against Iraq by launching missiles and bombs. In an address to the nation, President Bush says, “American and coalition forces are in the early stages of military operations to disarm Iraq, to free its people, and to defend the world from grave danger."
Severe acute respiratory syndrome (SARS) spreads to more than two dozen countries after being reported in February. According to the World Health Organization, the outbreak sickened 8,098 people. Out of that group, 774 people died.
Space Shuttle Columbia disintegrates over east Texas while making its landing descent. The disaster kills all seven astronauts. It marks the first time in American space flight history that there has been an accident on landing. The Columbia Accident Investigation Board concludes that that disaster was caused by a breach of the shuttle’s heat shield during liftoff. Image Caption: The STS-107 crewmembers pose for their traditional in-flight crew portrait aboard the Space Shuttle Columbia. Image courtesy of NASA.
The Contak CD/Easytrak system receives FDA approval, becoming the first device approved to offer heart failure patients both an implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy.
Bluetooth wireless technology appears on the cover of MD&DI for the first time.
http://www.devicelink.com/mddi/archive/02/02/001.html
MD&DI gives readers an exclusive guide to microfabrication and how they can incorporate the trendy technique into manufacturing.
http://www.devicelink.com/mddi/archive/01/11/001.html
Letters contaminated with anthrax spores are sent to news media, Senate majority leader Tom Daschle (D–SD), and senator Patrick Leahy (D–VT). The anthrax attacks infect 22 people, killing five.
Terrorists hijack four planes in the largest attack on American soil.
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