The Ingredients: Bromfenac Sodium
Dosage Form and Administration: Solution/drops; Ophthalmic
U Drug Trade Name: Bromday
Firm: Ista Pharms Inc
Strength: 0.09%
New Drug Application Type: N
The Drug Application Number: 21664
Medicine Product Number: 2
Approval Date: 10/16/2010
Reference Listed Drug: Yes
Type: RX
Applicant Full Name: Ista Pharmaceuticals Inc
Local Number: 22678

Institute on Alcohol Abuse and Alcoholism

National Institute on Alcohol Abuse and Alcoholism provides leadership in a national effort to reduce problems related to alcohol. The National Institute on Alcohol Abuse and Alcoholism conducts research in a range of scientific areas, including genetics, neuroscience, epidemiology, and studies the health risks and benefits of alcohol consumption, prevention and treatment. The National Institute on Alcohol Abuse and Alcoholism coordinates and collaborates with other research institutes and Federal programs on issues related to alcohol. The National Institute on Alcohol Abuse and Alcoholism collaborates with international, national, state and local institutions, organizations, agencies and programs to translate and disseminate research findings to health care providers, researchers, policymakers and the public.

Obstetrician/Gynecologist

Obstetrics and gynecology are the two surgical–medical specialties dealing with the female reproductive organs in their pregnant and non-pregnant state, respectively, and as such are often combined to form a single medical specialty and postgraduate training program. This combined training prepares the practicing OB/GYN to be adept at the surgical management of the entire scope of clinical pathology involving female reproductive organs, and to provide care for both pregnant and non-pregnant patients. Obstetrician/gynecologist is a physician specialist who provides medical and surgical care to women and has particular expertise in pregnancy, childbirth, and disorders of the reproductive system. This includes preventative care, prenatal care, detection of sexually transmitted diseases, Pap test screening, and family planning. An obstetrician is a medical doctor who specializes in the management of pregnancy, labor, and birth. Obstetricians also receive specialized education in the health of the female reproductive system and surgical care. Much of their education focuses on the detection and management of obstetrical and gynecological problems. An obstetrician/gynecologist, commonly abbreviated as OB/GYN, can serve as a primary physician and often serve as consultants to other physicians. OB/GYNs can have private practices, work in hospital or clinic settings, and maintain teaching positions at university hospitals. OB/GYNs may also work public health and preventive medicine administrations. OB/GYNs have a broad base of knowledge and can vary their professional focus. Many develop unique practices, providing high-quality health care for women. OB/GYNs may choose to specialize in the following areas: An obstetrician closely monitors their patient's health during pregnancy and delivery. They diagnose fetus abnormalities or health issues of their patient and offer healthy living advice and treatment. They see their patients on a regular basis for health consultations, ultrasounds and any of their patient's prenatal medical needs including forming a birth plan. The frequency of a patient's check up often depends on risk factors and resources. Gynecology is a branch of medicine specializing in the disorders of the female reproductive system. Modern gynecology deals with menstrual disorders, menopause, infectious disease and development of the reproductive organs, disturbances of the sex hormones, benign and malignant tumor formation, and the prescription of contraceptive devices. A branch of gynecology, reproductive medicine, deals with infertility and utilizes artificial insemination and in-vitro fertilizations, a human egg fertilized in a test tube, and then implanted into the womb. Some gynecologists also practice obstetrics. Surgical gynecology began to make progress in the 19th century, when the introduction of anesthesia and antisepsis (see antiseptic) paved the way for many advances. The American physician J. M. Sims was largely responsible for gaining acceptance of gynecology as a medical and surgical specialty. Until then there had been opposition to it on moral grounds from midwives, the clergy and the medical profession.

FDA Medical Device Registration

Owners or operators of places of business that are involved in the production and distribution of medical devices intended for use in the United States must register annually with the FDA, which is a process known as establishment registration. Congress has authorized FDA to collect an annual establishment registration fee for device establishment registrations. A detailed list of all those establishment types that have to pay the registration fee is available at "Who Must Register, List and Pay the Fee." There are no reductions in annual establishment registration fees for small businesses or any other group. Most establishments that are required to register with the FDA are also required to list the devices made there and the functions of those devices. If a device requires pre-market approval or notification before marketed in the U.S., then the owner/operator should also submit the FDA pre-market submission number. The amendments to the Medical Device User Fee Modernization Act require that after September 30, 2007, all businesses submit registration and listing information electronically. Registration and listing provides the FDA with the location of medical device establishments and the devices manufactured at those establishments. This information augments the ability of the United States to prepare for and respond to public health emergencies.

Concierge Medicine

Concierge medicine goes by many names, boutique medicine, retainer medicine, executive health, VIP medicine, and personalized medicine. By any name, concierge medicine is the solution for doctors trying to maintain their integrity and independence in today’s difficult healthcare environment.Concierge medicine is a new style of practice with old roots, in which doctors limit their patient base in order to provide patients with personalized service, high quality care, 24-7 availability, and other amenities. In exchange for this enhanced personal attention, patients pay physicians an annual fee. This concierge fee enables physicians to increase their compensation while managing their workload. In addition to receiving an annual fee, most concierge physicians continue to receive reimbursements from health plans and private pay clients. Concierge medicine is a relationship between a patient and a primary care physician in which the patient pays an annual fee or retainer. This may or may not be in addition to other charges. In exchange for the retainer, doctors provide enhanced care. Other terms in use include boutique medicine, retainer-based medicine, and innovative medical practice design.The practice is also referred to as membership medicine, concierge health care, cash only practice, direct care, direct primary care, and direct practice medicine. While all concierge medicine practices share similarities, they vary widely in their structure, payment requirements, and form of operation. In particular, they differ in the level of service provided and the amount of the fee charged. There are an estimated 5,000 concierge, or membership medicine doctors throughout the U.S. Concierge physicians care for fewer patients than in a conventional practice. All generally claim to be accessible via cell phone or email at any time of day or night or offer some other special service beyond the normal care provided. The annual fees vary widely, from $600 to $5,000 per year for an individual, with the lower annual fees being in addition to the usual fees for each service and the higher annual fees including most services. Some concierge practices do not accept insurance of any kind. These are as cash-only or direct primary care practices. By refusing to deal with insurance companies, these practices can keep overhead and administrative costs low, thereby providing affordable healthcare to patients. They become concierge only if the practice assesses an annual or monthly fee instead of or in addition to a fee for each medical service. Other concierge practices do take insurance, even Medicare, but ask for an annual fee for additional services exclusive of insurance plans. This annual fee is not a substitute for medical insurance, and generally does not cover consultations outside the practice, laboratory procedures, medicines, hospitalizations, or emergency care from other providers.