Advice Pool - Health and Fitness

Genital warts are contagious and they are spread during sexual activity. The virus that causes genital warts is the human papillomavirus. There are 100

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

types of HPV and 40 of them are spread through sexual contact.

Genital warts can spread during oral, vaginal or anal sex with an infected partner. Abou

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

two thirds of people who have sexual contact with a partner who has genital warts will develop warts, usually within three months of contact.

The only

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

way to prevent genital warts from spreading is to avoid direct contact with the virus, which is transmitted by skin to skin contact. If you or your sexu

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

l partner has warts that are visible in the genital areas, you should avoid any skin to skin contact to avoid spreading genital warts.

Unfortunately, m

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

any people who have HPV but who have no symptoms don’t know that they can spread the genital warts virus to an uninfected partner. At any given time onl

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

a small percentage of people who have genital warts have warts that are easily seen. A recent study by the National Institute of Health reported that a

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

most half of women who are infected with HPV had no obvious symptoms. Some people have reported reduced incidence of genital warts when a condom is used

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

but there is not formal scientific evidence to support that theory.

Pregnant women who are infected with HPV and suffer from genital warts are likely t

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

o be concerned about passing this extremely common sexually transmitted disease on to their child. Although it is not curable, genital warts do not gene

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ally spread to the newborn and are not a major threat to your child’s health during pregnancy.

In some cases pregnant women have genital warts so large

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

that they block the birth canal and make a vaginal birth impossible. There is also the risk that the warts may begin to bleed as the baby passes through

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

the birth canal. In some instances, it may be necessary for a woman to have a cesarean section either if the warts completely block the birth canal or i

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

f the warts are at risk of bleeding excessively during birth.

A good source of information about how genital warts can spread is the National Institute

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

For Allergies and Infectious Diseases. NIAID supports basic and applied research to prevent, diagnose and treat infections diseases. NIAID is part of th

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

National Institutes of Health.

Although there is no cure for HPV, considerable research has been performed regarding the prevention of the infection.

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

n June of 2006, the Food and Drug Administration approved Gardisil, the first vaccine developed to prevent genital warts. Some states are considering ma

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

king the vaccine mandatory for girls when they turn 13. There has been heated political debate over whether or not the vaccine should be mandatory. In a

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

y event, the focus on prevention could play a key role in reducing the spread of genital warts in this country.

Glossary: Gardisil: A

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

vaccine to prevent genital warts that has been approved by the Food and Drug Administration. Human papillomavirus: The virus that causes genital warts

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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