There is an urgent need for more trained professionals who understand and are able to apply international regulatory standards. Courses at ASU prepare our students to operate under strict international regulatory norms. Recently many Indian manufacturing units are falling afoul of the US-FDA drug regulations. The latest to do so is the Indian subsidiary of the Canadian drug company Apotox. 


WASHINGTON (Reuters) - An Indian subsidiary of Canadian drug company Apotex Inc manipulated laboratory data, retesting samples until the results were acceptable, according to a warning letter posted by the U.S. Food and Drug Administration on its website on Tuesday.

Read the source article at Business News

Stem cell behavior can be modified by manipulating the nanoscale properties of the material they are grown on -- improving the potential of regenerative medicine and tissue engineering as a result, researchers report. In this study, the researchers used tiny material patches known as nanopatches to alter the surface of the substrate and mimic the properties of a softer material.

Read the source article at ScienceDaily

May 30, 2014 -- The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.

“It is important for patients to have access to affordable treatment options for chronic conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards.”

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This is the right way for state governments to deal with public health crisis - by tendering for generic quality medicines. Rather than artificially lowering prices that damages market systems, lead to poor quality medicines, and does not solve the prescription and distribution problem. 

From The New Indian Express: 

Free medicines are being provided to drug addicts in Punjab as part of a special de-addiction campaign being organised in the state.

 CHANDIGARH: Free medicines are being provided to drug addicts in Punjab as part of a special de-addiction campaign being organised in the state.

Patients attending the Out Patients Departments (OPDs) of all community health centres, sub-district hospitals and district hospitals for de-addiction treatment are being provided free medicines, a spokesman said here today.

Read the source article at The New Indian Express

Damien Conover talks about emerging markets and the channels for pharmaceutical companies to succeed there. 

Damien Conover: When we look at the pharmaceutical landscape over the last few years, we’ve seen valuations improve significantly. A lot of this is being driven by three key areas. The first of which is the end of the patent cliff, which really peaked in the 2012 time period. The second point is the growing importance of emerging markets, which are offering a new channel of demand for pharmaceutical products. The third reason has to do with increased productivity in the pipelines, which will bring forward next-generation drugs at a much faster rate than what we have seen for some time.

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