Clinical Operations-Design to Execution

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 In October, 2009,Center for Biologics Evaluation and Research (CBER), FDA, has issued a draft guidance to potential sponsors (cord blood ...

BayBiotech.NET A well planned regulatory strategy in the initial phase of product development is an essential component to safely and effectively launch the FDA regulated product in the market. However, preparing an effective strategy leading to commercialization of the product depends on many factors and one of the most important factor is to determine the class and subcategory of the product to be developed. For example if you plan to develop a drug, then must subcategorize it as over-the-counter, new drug, generic drug etc. Once the class and subcategory is identified, then local, state, federal and international guidelines must be reviewed thoroughly for understanding the regulatory needs for the particular class and subcategory of the product. Next step followed will be to prepare a risk/ benefit analysis and targeted pre-clinical experiments to demonstrate the safety and efficacy of the product as well as developing different protocols for procurement, experimental procedure...

BayBiotech.NET Since 1976, National Cancer Institute (NCI) in agreement with FDA has established the Group C classification system to allow access to certain drugs for the cancer patients specifically falling under a category that adequate alternative therapy or if the available alternative therapy has significant toxic effects. Each Group C drug protocol specifies patient eligibility and drug use information. Group C drugs are provided only to properly trained physicians who have registered themselves with NCI using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Physicians using drugs under Group C have no reporting requirements to the NCI other than the obligation to report adverse drug reactions. Group C drugs are provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy. Making Group C drugs available to the critically ill patients not only provi...

BayBiotech.NET The Medpedia Project has established a platform ‘Medpedia Clinical Trials’ for patients, researchers and physicians to receive information about the thousands of clinical trials that are in process or about to begin worldwide. The information on various clinical trials is updated regularly from ClinicalTrials.gov and can be searched using different attributes with basic and advanced search functionalities. Medpedia Clinical Trials platform allows visitors to leave their comments, thoughts and views on a specific clinical trial page. Most importantly, a personalized feed can also be obtained if someone is interested in learning more about on-going or about to start clinical trials on a particular condition worldwide. Moreover, if you are reading a Medpedia article on a particular clinical condition, the information on the related clinical trials are fed automatically alongside the article page. To learn more about it visit http://www.medpedia.com/clinical-trials .

BayBiotech.NET As per ICH guidelines, the overall aim of an Investigator’s Brochure is to provide the investigator with a clear understanding of the possible risks and adverse reactions, and of specific tests, observations and precautions that may be needed to conduct a clinical trial maintaining the safety of the patients enrolled for the study. This information must be based on scientific data produced by performed physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information of the investigational drug or device. Based on the scientific studies, the Investigator’s Brochure is intended to provide the Investigator with necessary management of study subjects throughout the clinical trial. Main focus must be given to the following measures: A. Dose B. Frequency of the dose C. Method of administration D. Safety monitoring procedures E. List of abbreviations and acronyms F. Description of the formulation of the drug G. Instructions for the storage ...

BayBiotech.NET Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices. Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency. GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review. As a result of the report, FDA has committed to address al...