The guidance of use Real World Data (RWD) and RWE for medical devices was released in August 2017 and was to provide clarifications of how and what RWD and RWE could be used in FDA regulatory process. This guidance included the criteria for sufficient quality of RWD to generate RWE for medical device use. Read more
In order to determine the suitability of Real World Data (RWD) for regulatory decision-making, the FDA will assess the relevance and reliability of the source and its specific elements. Important factors associated with RWD relevance primarily are: 1) sufficient details 2) capability to address specific questions 3) interpretable using informed clinical/scientific judgement. Reliability of RWD is associated with data accrual and data assurance. Data assurance consists of the quality of data element population, adherence, completeness, consistency and program evaluation process. Read more
Relevance and reliability of RWDIn order to determine the suitability of Real World Data (RWD) for regulatory decision-making, the FDA will assess the relevance and reliability of the source and its specific elements. Important factors associated with RWD relevance primarily are: 1) sufficient details ; 2) capability to address specific questions; 3) interpretable using informed clinical/scientific judgement. Reliability of RWD is associated with data accrual and data assurance. Data assurance consists of the quality of data element population, adherence, completeness, consistency and the program evaluation process. Read more
This framework is for evaluating the potential use of Real World Evidence (RWE) to help support the approval of a new indication for drugs and biological products already approved or to help support or satisfy drug post-approval study requirements. This framework is also intended for application to biological products licensed.
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In December of 2018, the FDA published their Framework for FDA’s Real-World Evidence Program, which outlines the allowed usage of Real World Data (RWD) and Real World Evidence (RWE) in FDA submissions.
The rationale for using Real-World Data (RWD) is to help support the approval of a new indication for a drug approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to help support or satisfy post-approval study requirements. Read more
The FDA has updated and modernized its clinical trial designs. That means a lower cost, more efficient process leading to a more competitive market and lower prices. Not only will this make it easier to bring new treatments to market, it will also increase the amount of similar treatments. That means shorter time frames for companies first to market to have a monopoly over treatments. It also means patients have greater choice within a class of drug. Read more
None of your partners are trying to make your late stage approvals process difficult. But they might be doing it anyway.
It’s not uncommon for the root of a problem to lie not with your organization, but with a partner CRO. Here are some of the most common ways partner organizations can complicate your FDA approvals process: Read more
In a sense, FDA regulations are a game of political football. The goal posts are always moving. As new administrations come in, so do new administrators. The current year is no different, with a number of areas shaping up to be contentious points with regard to FDA approvals.
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Everything can be going wrong, but late stage analysis can save the day for your new treatment.
Previously, we discussed how the Phase Three clinical trials and approvals process is significantly more difficult than the first two combined. Late stage analysis can save the day for many organizations. Read more
There’s no two ways about it: Submitting your work is significantly more difficult than earlier stages of clinical trials. That’s because you have to integrate all of your previous analysis into a single, cohesive whole. Those studies might stretch back as far as a decade. What makes the process even more challenging is that these studies must conform with current FDA standards.
You will get some guidance at the end of Phase Two, but that guidance might not be worth much by the time Phase Three comes along. It will have driven your research and analysis throughout Phase Three, but it won’t tell you much about how you should present your data and analysis to the FDA when it comes time for Phase Three approval. Read more