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

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

BayBiotech.NET HBD is an international cooperative effort by Japan and US for regulatory convergence for Medical Devices. The efforts are focused on to develop global clinical trials and address regulatory barriers for timely device approvals. To address the needs for additional evaluation, the HBD initiative is a pilot project launched jointly by FDA and MHLW-PMDA for the premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD is focused on Proof of concept by utilizing parallel development, application submissions and review of actual medical device projects. HBD Study intends to collect and analyze regulatory submission data from multiple applications in the U.S. and Japan. The purpose of the study is to further understand differences that may exist with format and content, to define best practices and to improve globally harmonized processes. To read more about the HBD program, follow the link: http://www.fda.gov/M

BayBiotech.NET ISO 10993 describes a set of standards for evaluating the biocompatibility of a medical device prior to a clinical study. Based on these guidelines, agency’s modified guidelines entitled "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing," describes a FDA-modified matrix that designates the type of testing needed for various medical devices. Main criteria to consider when selecting the appropriate tests for biological evaluation of a medical device are the chemical characteristics of device materials and the nature, degree, frequency and duration of its exposure to the body. In general, the main type of tests include: acute, sub-chronic and chronic toxicity; irritation to skin, eyes and mucosal surfaces; sensitization; hemocompatibility; genotoxicity; carcinogenicity; and, effects on reproduction including developmental developmental effects. However, depending on varying characteristic

BayBiotech.NET The eCTD submission requires construction of XML based backbone for the submission with strict guidelines for file name size, pdf style and hypertexting format. Although the XML based backbone is a choice for submission as it gives an advantage by making the submission independent of operating system environment, but also imposes some issues for a successful submission. In order to avoid the pitfalls and delay in response of obtaining RTF (refuse-to-file) along with the expertise in preparing high quality .pdfs for submission and expertise in XML is also required. On analyzing the various tools available in the market, my recommendation will be to use caution in using such tools without double checking the submissions and having an independent quality check of your own as such tools are still at prelim phases of development and as a sponsor you may not wish to bet your million dollar investment on a RTF. A good quality .pdf, an accurate XML coding as well as strict