Controls Rld
 |
| No items matching your keywords were found. |
Controls Rld
The 505(b)(2) Process: Using Information in the Public Domain for Proof of Safety and Efficacy
In a 505(b)(2) submission, the FDA expects the Sponsor to sort the evidence into relevant information, and will not accept a non-sorted list of publications with the expectation that the FDA sorts this list for the Sponsor to support their submission.
While Google may be used as part of the search process to be thorough, there are more targeted search engines available. Depending on the information that is required of the submission, searches using PubMed, Chemical Abstracts, MedWatch, Approved Product Labeling and the FDA Center for Drug Evaluation and Research (CDER) website often prove valuable.
What is required of the 505(b)(2) submission is evidence to support clinical safety or efficacy of the candidate in the form of published controlled trials. Each supporting article needs to be reviewed, prioritized for evidence of safety and/or efficacy, and then summarized. The summary will evaluate the dose, patient population, indication, duration of treatment, primary and secondary endpoints and safety, including, for example, drug-drug interactions. Review articles and research articles with less than significant data are often included in the literature review for completeness, even though FDA considers them secondary. For prioritization of evidence to support safety and efficacy of the candidate, the sponsor should use the following criteria ranked in the following order use the following criteria ranked in the following order: 1) Placebo-controlled trials, 2) Dose-response trials where patients are randomized to different fixed-dose groups, 3) Active -controlled trials that show superiority of the proposed drug over the RLD, and 4) active-controlled trials that show no difference would be last. These clinical trials are also distinguished based on whether they are blinded or open-label. Blinded trials give a higher level of evidence than do open-label trials.
All of this information is needed at the pre-IND stage because the Sponsor needs to take away from this meeting a concurrence with the FDA on your candidate’s development plan. The development plan is based on what is known and what is needed. Without a good grasp of what is known through review and prioritization of the public information, the FDA may or may not be able to give adequate advice.
The sponsor should use this information to develop a feasibility report in order to determine whether to move ahead with a pre-IND meeting. A benefit of preparing the feasibility review and the pre-IND report is that once the public information is properly catalogued and summarized in the feasibility review and the pre-IND reports, the information can be quickly inserted into the IND and NDA for rapid submission to the FDA.
About the Author
Dr. Maguire has spent over 20 years in research and development as a professor of neuroscience and ophthalmology at the UCSD School of Medicine where he was awarded an NIH Fogarty Fellowship and ran an NIH- and NSF-grant supported research laboratory. Dr. Maguire holds numerous patents for drugs and devices, has over 100 publications in the areas of neuroscience, ophthalmology, cancer, and pharmaceuticals, is a founder and director of two biotechnology companies and two non-profit life science organizations, and has led the implementation of several large BD contracts between biotech and big pharma companies. He serves on the Scientific Advisory Board of several health care companies and routinely lectures around the world on health care and pharmaceutical related issues.
I got into a car accident, where should I go?
I got into a car accident with this black guy in the RLD. I rear-ended him as he slowed on the yellow light. The idiot drives so perfectly you'd think a computer was controlling him. Anyways, we got out to inspect the damage, and I explained that it was his fault because yellow lights are irrelevant in the red light district. I don't think he heard me though. He kept saying the same thing over and over: "My mother's my sister!" A few racial slurs were exchanged, and than later so were fists and one superb Ong-Bak, Jet-Li, Kung-fu Panda, high flying elbow smash connector that sent him off his feet. I'm want to go to the police department to report this idiot, but I can't find it on the Grand Theft Auto map. Is there a police department on the second island? Would 8-Ball be able to help me?
So this is a video game situation. Ahhh very nice. I would get the shotgun and start shooting up the streets.
SR Suntour Epicon SF9-RLD 120mm