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

Pediatric Research Equity Act (Dec, 2003) requires pediatric studies of certain drugs and biological products unless waived or deferred. The law mandates a pediatric assessment for applications with new ingredients, new indications, new dosage forms, new dosing regimens or new routes administration. PREA also requires that the studies must be designed to pose minimal risks and direct benefit. For a course of disease or effect similar to adults, effects can be extrapolated from the studies conducted in adults. To read more about the PREA, click here.

BayBiotech.NET The Hazardous Waste Source Reduction and Management Review Act of 1989 applies to large quantity generators that produce more than 12,000 kilograms (13.2 tons) of hazardous waste, or 12 kilograms (26 pounds) of extremely hazardous waste, in 1990 and every four years thereafter. The law requires the generator companies of such hazardous waste to: • Conduct a source reduction evaluation of their facilities and prepare the following:  Source Reduction Evaluation Review and Plan (Plan)  Hazardous Waste Management Performance Report (Report)  Summary Progress Report (SPR) • Implement feasible methods for reducing the quantity and/or the hazardous characteristics of routinely generated hazardous waste. The main purpose of requiring generators to review and implement source reduction practices is to reduce the quantity of hazardous waste generated in California and thereby to promote public health and safety and to improve environmental quality. Such a source

BayBiotech.NET On April 19th, 2010 FDA launched he Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative. The Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format. The site includes new information such as basic information about medical devices and how FDA regulates those products, information about medical devices before and after the products are on the market, in a searchable database, information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices, memos from FDA employees explaining the reasons for the agency's decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device as well as a step-by-step guide for manufacturers of

BayBiotech.NET While a biotech start-up faces numerous challenges, it must give a top priority to incorporate compliance and quality standards from the beginning in day to day operations. Due to the nature of business for a biotech, it is of utmost importance to understand the regulations around the line of product and implement into the business for future audits and mitigations. A key element in developing successful regulatory strategy is to prepare a plan that is simple enough to be understood and communicated by all—the business, technical, and legal staff—who will ultimately be responsible for carrying out the plan. Apart from compliance, there are several other key points that a start-up biotech must consider and focus on to make the most of it’s intial investments for future growth. To read more about it, follow the link: Top 10 Legal Issues Biotech Start-Ups Must Address.

Food and Drug Administration (FDA) and the National Institutes of Health (NIH) l have launched a new Web site for industry to report food safety problems or adverse events involving FDA-regulated foods (except for dietary supplements and infant formula), animal feeds, and animal drugs. Consumers can also use the site to report problems with pet foods and pet treats. The new site has been launched on May 24, 2010 is called the Safety Reporting Portal (SRP) and provides greater and easier access to online reporting. You can click here to navigate through the website.

BayBiotech.NET U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) is collecting information and comment on occupational exposure to infectious agents in settings where health care is provided, including hospitals, outpatient clinics, school clinics and correctional facilities, and settings such as laboratories that handle potentially infectious biological materials, medical examiner offices and mortuaries. In order to implement safe working environment, main objective is to collect information and data on the facilities and the tasks potentially exposing workers to this risk in order to implement successful employee infection control programs. More information on the request for information and how to submit comments is available at http://s.dol.gov/38. Comments may be submitted by Aug.4, 2010.

BayBiotech.NET International efforts to complete the human genome project and HapMap (Haplotype mapping of human genome) projects channelized the development of Division of Personalized Nutrition and Medicine (DPNM). Data generated from these projects made us to think in the direction of personalized medicine emphasizing that even though humans are genetically similar, each retains a unique genetic constitution that contributes to the wide array of biochemical, physiological, and morphological phenotypes in human populations. The unique identity is mostly shaped by nutrients and environment in which an individual lives. DPNM is geared to develop and implement research strategies that account for genetic, environmental, and cultural diversity that influence expression of genetic makeup and produce knowledge for improving personal and public health. Within DPNM, there are two active divisions—Biometry and Biology. While, Biometry branch works to develop biometrical methods for all asp