iwewlkws Reviewers of papers submitted to journals can be biased towards authors with established credentials; for example, an article with a Nobel Laurette as an author is about 6 times more likely to get published without any significant comments compared to one by novice authors. This can be addressed by anonymizing the authors of the publication. … Read more
For developers of medical devices using artificial intelligence (AI) and/or machine learning (ML) tools, precedent information is critical. Being a new field, there are few public resources to plan and strategize development steps for FDA approval. FDA’s list of AI/ML-enabled medical devices is hence a priceless gift to the developers. FDA has been maintaining this … Read more
This week the US Congress unanimously cleared the Bill S.5002 which requires FDA to allow alternatives to animal testing for drug and biological applications. While there is a strong bi-partisan political support in the US for this bill, in practicality it may have minimal impact on the animal tests required by FDA. Animal testing is … Read more
Including children in clinical trials poses unique challenges and FDA’s latest guidance document on the topic acknowledges and highlights all the reasons why so few trials are done in pediatric subjects. The guidance confirms the conventional wisdom that trials in children must be adequately justified, properly designed to minimize risk to children, and avoided if … Read more
This week, FDA formally announced that it has stopped accepting Emergency Use Authorizations (EUAs) for most Covid diagnostic tests. While this should not come as a surprise to most, this announcement should settle this issue for anyone still hoping to submit an EUA for such tests. EUAs are an important tool for rapidly releasing unapproved … Read more
This week, President Biden’s statement that the “pandemic is over” created a media storm. Public health experts were split on if the statement was premature or if it is time to move on from the classical definition of the pandemic. From a regulatory point of view, the statement from the President could indicate a significant … Read more
Starting next year, FDA would stop accepting 510k applications as paper submissions or even as an eCopy loaded on to a DVD or a flash drive. The only acceptable format for submission of an electronic 510k applications would be those created using the eSTAR template released earlier this year. While electronic submission of clinical trial … Read more
Validation of software used in manufacturing processes such as for automation or quality control functions should not only be validated prior to use, but also follow a life cycle testing program to maintain an acceptable level of assurance of quality performance. Basically, FDA expects a similar life-cycle approach for periodic testing of critical software as … Read more
IND, NDA and BLA submissions containing real-world data and real-world evidence (RWD/RWE) should highlight that info in the cover letter to that submission, according to the latest FDA guidance on best practices for the using such data to support claims in an application. While the guidance may seem mundane to an untrained eye, this highlights … Read more
Last year, the most common FDA 483 finding from inspections of drug manufacturing sites was non-compliant handling of deviation investigations and inadequate quality unit oversight. Inadequate CAPA, data integrity issues, and deficiencies in training of personnel wrapped up the top 5 major findings by FDA inspectors. The annual report on the GMP compliance in the … Read more
