Life is a Journey..how to make the best of it!

BayBiotech.NET Interstate shipment(which includes importation and exportation) of unapproved new drugs is prohibited by the Federal Food, Drug, and Cosmetic Act.Clearly, the drugs that lack approval if imported either for personal use or otherwise,violates the Act.In this context,the definition of unapproved new drugs include any drugs--including foreign-made versions of U.S. approved drugs--that have not been manufactured in accordance with FDA approval. Imported products regulated by the FDA are inspected at the time of entry by the U.S. Bureau of Customs & Border Protection (Customs) and the shipments that are not found to comply with the law must be either brought into compliance, destroyed, or re-exported. The importation and exportation of controlled substances requires compliance with provisions enforced by the U.S. Drug Enforcement Administration (DEA). Further information on compliance can be obtained at the DEA Office of Diversion Control website . A draft gu

BayBiotech.NET Stem Cell Therapy although holds promises for the treatment of many diseases, this is an area not much explored yet and many countries worldwide are drafting the guidelines for conducting safer clinical trials. Therefore, it is accepted widely that prior to conducting clinical trials with stem cells a stronger than usual proof of concept may be required for the safety and efficacy of the therapy. One of the major concerns is the rapid cell division cycles of such cells that may lead to tumor generation. Thus, it is recommended that the dose of administered cells to humans must be well adjusted to below the minimum number of cells observed to form tumors in animal models. Due to many unanswered questions regarding the safe use of stem cells a long-term follow-ups and Biovigilance must be planned carefully before starting a trial. In October, 2009,Center for Biologics Evaluation and Research (CBER), FDA, has issued a draft guidance to potential sponsors (cord blood