• Doctors to FDA: No Cold Medicines for Kids
• FDA to Apply GIVE to Hasten Generic Drug Approval
• HIV AIDS Vaccine in the Making?
• Sale of Anti-Bleeding Drug Halted
• High Blood Pressure May Vary by Season
• Doctors to FDA: No Cold Medicines for Kids
Following several high profile voluntary withdrawal of children's cold medicine in the USA, expert advisers to the FDA began a 2-day meeting to consider a petition from paediatricians on the use of cold medicines for children. In a statement, the physicians say OTC cold medicines should not be used in children under 6 because they are ineffective and unsafe. The drug industry maintains the commonly used medicines are safe but can lead to overdoses when misused in infants. The FDA has yet to act on the petition.
The controversies continue and on 30-Oct-07, our HSA has issued a Dear Healthcare Professional letter on this which PSS has already distributed to all our members through email blast.
• FDA to Apply GIVE to Hasten Generic Drug Approval
The US FDA has outlined a programme called Genric Initiative for Value and Efficiency, or GIVE. This is aimed at enhancing the accessibility of generic drug products, both to the consumers and health care providers. Generic drugs generally cost less than their brand-name counterparts and competition among generics has been a key factor in lowering drug prices.
The GIVE programme will help the FDA modernize and streamline its generic drug approval process. The FDA approved or tentatively approved a record of 682 generic drugs products in fiscal year 2007, over 30 percent more than the previous year.
FDA now has about 215 full-time staff working on the review of generic drug applications. Under GIVE, FDA will hire and train new generic drug reviewers and focus on enhanced use of electronic programs for handling drug submissions and internal documents. When possible, resources from
other FDA departments will be engaged in the effort. As well, FDA will increase its communications with generic drug manufacturers and provide training on proper application submission to the industry in meetings and webcasts.
Generic drugs undergo a rigorous scientific review to ensure that they are of high quality, safe, and effective. Generic drug manufacturers must demonstrate that a generic drug are equivalent to the original proprietary product. Bioequivalence is a critical requirement for concluding that the original and generic drugs will produce the same therapeutic results.
• HIV AIDS Vaccine in the Making?
Cuban scientists have developed a new HIV AIDS vaccine and successfully tested on animals. The next move is to perform clinical trials on human subjects. The vaccine would be of immense help in improving the post treatment of AIDS patients whether or not the drug is used in conjunctionwith or without retroviral drugs.
Scientists and researchers across the world have been working on vaccines to treat AIDS but none have quite come out as successful. Some developments offered vaccines which prolong the lives of AIDS patients but they are too expensive to be used at public scale, especially in poor countries such as India and Africa continent.
• Sale of Anti-Bleeding Drug Halted
The Food and Drug Administration has asked the makers of Trasylol, a drug used to prevent excessive bleeding during heart by-pass surgery, to withdraw the medication pending further analysis of a Canadian study which linked the drug to an increased mortality risk. The suspension may be only temporary as the FDA is exploring whether to make the drug available on a restricted basis for use by physicians in certain patients.
As Reported by The New York Times
• High Blood Pressure May Vary by Season
A study presented at the American Heart Association's 2007 Scientific Sessions finds that the blood pressure of people with hypertension is more likely to return to normal levels in summer than in the winter. Researchers found that blood pressure was nearly 8% less likely to return to normal in the winter than in the summer, suggesting that some people with high blood pressure may need higher doses or different medications during the winter months. A lack of exercise and a tendency to gain weight during the winter may play a role in the seasonal variation of blood pressure, researchers concluded.
As Reported by CBS News / WebMD
**********
