Cosmetic Jersey New Surgeon
Updates-October 1995 FDA Consumer
(For more about impotence treatment, see "Inflatable Penile Implants Under Scrutiny" in the January-February 1994 FDA Consumer.) New Indication for Cholesterol-Lowering Drug The approved cholesterol-lowering drug Zocor (simvastatin) was recently approved by FDA for a new use--reducing deaths and preventing heart attacks in people with heart disease and high cholesterol. It is the first cholesterol-lowering drug approved for this use. ... Free samples are obtained by children, including those in elementary school, despite industry code prohibiting distribution to anyone under 21. Free samples are distributed on street corners, in shopping malls, and at sporting events. A New Jersey survey found that one-third of high school students who were smokers or ex-smokers reported receiving free samples before age 16. ... [Read More]
PCBE: Reproduction and Responsibility: The Regulation of New Biotechnologies: Assisted Reproduction
22. New York State Task Force on Life and the Law, Assisted Reproductive Technologies: Analysis and Recommendations for Public Policy , New York: New York, 1998, p. 63. ... Particular techniques raise certain specific concerns in this regard. Cryopreservation, ooplasm transfer, and the possible use of fetal oocytes directly raise concerns about the definition and identity of “father” and “mother.” Cryopreservation of sperm and embryos makes posthumous parentage possible. For instance, some American soldiers have been reported to store up sperm on the eve of shipping out to a battle zone. And instances have been reported in which women have requested that their newly deceased husband’s sperm be harvested via assisted sperm retrieval from the corpse and used for artificial insemination. If techniques for cryopreservation of ova are ever perfected, or if ova can be derived from adult stem cells, new opportunities for posthumous conception involving deceased women will also arise. ... [Read More]
US FDA/CFSAN - Curriculum Vitae: J. Michael McGinnis
J.M. McGinnis, "The Tithonus Syndrome: Health and Aging in America," in R. Chernoff and D. Lipschitz, eds., Health Promotion and Disease Prevention in the Elderly , New York: Raven Press, pp. 1-15 (1988) J.M. McGinnis, "Suicide in America--Moving Up the Public Health Agenda," Suicide and Life-Threatening Behavior ,Vol. 17, No. 1, pp. 18-32 (Spring 1987) R.E. Windom, J.M. McGinnis, and J.E. Fielding, "Examining Worksite Health Promotion," Business and Health ,Vol. 4, No. 9, pp. 36-37 (July 1987) J.M. McGinnis, D. Shopland, and C. Brown, "Tobacco and Health: Trends in Smoking and Smokeless Tobacco Consumptionin the United States," Annual Review of Public Health , Vol. 8, pp. 441-67 (1987) J.M. McGinnis, "A Healthy Campus--Forecasting from the 1990 Health Objectives for the Nation," Journal of AmericanCollege Health , Vol. 35, No. 4 (January 1987) J.M. McGinnis, "Future of Worksite Wellness," in Health Task '86 , Health Insurance Association of America,pp. 126-130 (1986) J.M. M ... [Read More]
MMWR: Weekly Volume 53
Notice to Readers: Availability of Diphtheria Antitoxin Through an Investigational New Drug Protocol ... Indoor Air Quality in Hospitality Venues Before and After Implementation of a Clean Indoor Air Law --- Western New York, 2003 ... Physical Health Status of World Trade Center Rescue and Recovery Workers and Volunteers --- New York City, July 2002--August 2004 ... [Read More]
MedlinePlus: Plastic and Cosmetic Surgery
Cosmetic Plastic Surgery: Procedures at a Glance (American Society of Plastic Surgeons) ... Camouflage Cosmetics: Makeup Techniques After Plastic Surgery (American Society of Plastic Surgeons) ... 2004 Quick Facts on Cosmetic and Reconstructive Plastic Surgery Trends (American Society of Plastic Surgeons) - Links to PDF ... [Read More]
Interviews with surgical center staff indicated that the patients' surgeon used a water-based solution of methylene blue to mark incisions on exposed muscle during rhytidectomies. No other surgeons affiliated with the surgical centers used methylene blue in this manner. In addition, the surgeon used this dye only during rhytidectomies. All sources of methylene blue that were available when the patients had their rhytidectomies were removed from circulation and tested at the New Jersey Public Health and Environmental Laboratories. These sources included 1) a 4-ounce bottle of 0.5% unsterile methylene blue that was prepared commercially in September 1999 and found in an office at the surgical center where three cases occurred, 2) a tube containing dye, 3) a single syringe used to dispense dye into a cup during multiple rhytidectomy procedures, and 4) an opened, single-use vial of 1% methylene blue. Mycobacteria identified as M. chelonae were isolated from each source. ... [Read More]
Medical Glove Guidance Manual
If a new labeling claim is added, or a change is made, to gloves that couldsignificantly affect safety or effectiveness, such as adding or deleting powder, addingcolor, or modifying an important process, a new, complete 510(k) should be submitted. Anew 510(k) usually is not required if a manufacturer only does more of an existing processsuch as extra leaching or washing and makes no special claim or mention of this change onthe product labeling. A 510(k) submission for a new glove or for a modification to anexisting glove may be submitted according to the guidance titled, "The New 510(k)Paradigm - Alternative Approaches to Demonstrating Substantial Equivalence in PremarketNotifications," available on the World Wide Web at: ... [Read More]
NJ Office of The Attorney General - Department of Law & Public Safety
New Jersey Attorney General and Middlesex County Prosecutor Launch Anti-Gang Initiative in New Brunswick - Law Enforcement, Educators, Parents and Students Kick Off "PROJECT VISION New Jersey" - 90 Students Are Enrolled in After School Initiative ... Homeland Security Initiative Selected as “Best Practice” in New Jersey State Government - Urban Area Security Initiative includes Bergen, Essex, Hudson, Morris, Passaic and Union Counties, as Well as Newark and Jersey City ... [Read More]
FDA Updates--September-October 2004 FDA Consumer
A New Jersey judge has found that two products sold as dietary supplements and another touted as a cosmetic are unapproved new drugs under federal law because they were being marketed as treatments for cancer and HIV without FDA approval. The three products are BeneFin, a purported treatment for cancer, MGN-3, marketed as an HIV treatment, and SkinAnswer, promoted as a treatment for skin cancer. BeneFin is produced from shark cartilage, MGN-3 is a rice bran extract, and SkinAnswer is a skin cream. ... [Read More]
CDRH Consumer Information - TMJ Implants - A Consumer Informational Update
No, there is no new information. On December 28, 1990 FDA issued the first safety alertto all oral and maxillofacial surgeons warning them of serious problems. On July 15, 1994FDA sent a letter to physicians who treat TMJ patients and informed them of problems withTMJ implants. The letter went to orthopedic surgeons, otolaryngologists, and plastic andreconstructive surgeons because these physicians may treat TMJ implant patients. FDAwanted to make sure these physicians were aware of problems with TMJ implants so they maybe able to better treat a TMJ patient. ... [Read More]
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