Clinical Operations-Design to Execution

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...

BayBiotech.NET At present, the Indian market for medical devices is largely unregulated and Medical devices can freely be imported into India. Solely, the key decision maker is either the doctor, or a private or government hospital that evaluates the device and imports it to India. Although the FDA approved products are preferred because of their better quality and performance, but since India is a price sensitive market, low priced, poor quality medical devices find a bigger and more favored market. To ensure the quality of healthcare service and keeping the globalization of the clinical trials in mind, the Government of India is in the process of developing regulations for medical devices. A set of guidelines are expected to evolve that would bring a select group of medical devices under the regulatory framework. In India, the authority regulating medical devices will be the Central Drug Standard Control Organization (CDSCO) in the Ministry of Health. The CDSCO is the author...

BayBiotech.NET RoHS (Restriction of the Use of Certain Hazardous Substances) directive bans placing the new electrical and electronic equipments on the EU market containing more than agreed levels of lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants. These are the regulations under EU Directive 2002/95. The RoHS Directive and the UK RoHS regulations came into force on 1 July 2006. Since then, there have been amendments about exemptions regarding the levels of abovementioned articles in certain products. In order to get the latest on the exemptions as well as to understand the directive before manufacturing your product for the European market, follow the link: http://www.rohs.gov.uk/Default.aspx.

BayBiotech.NET Electronic Common Technical Document (eCTD) is an ICH standard adopted by FDA as a member of ICH, together with other member regions, Europe & Japan to facilitate electronic submissions to the agency. Harmonization of guidelines has been done to achieve global consistency in order to facilitate globalization of the drug discovery efforts. As of 2008, eCTD standard is the only acceptable format for new electronic submissions to the agency with an exceptions for submissions that are already under review. As the agency is working to standardize the eCTD process, it is encouraging the Industry to begin working on establishing a system for eCTD submissions. It is advisable to either use an in-house developed or commercially purchased e-CTD tool. In order to validate your eCTD tool, it will be important to pay attention to the following major issues identified by the agency regarding the eCTD submissions: 1. Lack of 356h, 1571, or 2252 forms in a submission. 2. Lac...