Clinical Operations-Design to Execution

BayBiotech.NET FDA launched its Critical Path Initiative (CPI) in March 2004, with the release of a report “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products”. This report highlights the reasons for the widening gap between modern scientific discoveries with a potential to prevent and cure some of today's biggest medical challenges, and their translation into innovative medical treatments. The main reason identified was being Industry’s apprehension to adapt and train to new technologies that might delay launch of the product into the consumer market. In order to ease out the apprehension, FDA recognized the need for a collective action to modernize the scientific and technical tools and introduced CPI and calls for incorporating specific activities into the medical development path that would help modernize the critical path sciences. CPI has seen the number of its projects grow from 40 in 2006 to 95 in 2009. FDA is collaborating wi...

BayBiotech.NET Before the onset of a trial the study director/sponsor must have a risk assessment and risk management plan to accompany the filing to IRB or FDA for IND or PMA applications. Hazard is defined as anything that could cause harm and risk is the probability of that harm caused by the hazard. Risk Assessment Plan for each potential hazard includes mapping and analysis of associated risks, its potential consequences and reasonable steps to reduce the risks. In a clinical trial hazards are categorized into main four groups: 1.     Hazards for the participants that encompasses protecting participant’s rights. 2.     Hazards for the participant’s safety by assessing the likely risk/ benefit ratio in the study population. 3.     Hazards of the trial with risk associated for recruitment and follow-up. 4.     Hazard to the reliability of the results mainly in terms of study power and adherence to the protoco...

Quality that Matters for Life Sciences Venture: Risk Evaluation and Mitigation Strategies Guidance for Pharmaceutics and Biologics BayBiotech.NET

BayBiotech.NET FDA has posted draft guidance for Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications on its website. The draft guidance has been posted in September 2009 and is open for comments and feedbacks from all that may have an interest in the subject. In a nutshell, the guidance authorizes FDA to require the applicants of NDA (new drug applications), ANDAs (abbreviated new drug applications), and biologics license applications (BLAs) to submit a proposed Risk Evaluation and Mitigation Strategies (REMS) within 180 days once notified by FDA and may come to the applicant, if FDA becomes aware that such a strategy might be necessary to ensure that the benefits of the drug outweigh the risks of the drug in question. Before September 2007, when the Food and Drug Administration Amendments Act of 2007 (FDAAA) was signed, FDA used to approve a small number of drug and biological products with risk minimization a...