iwewlkws 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
An independent study found that more than 76% of the drugs approved under the accelerated approval pathway (AAP) in the US did not demonstrate any additional therapeutic benefits compared to the previously available treatment options for the same indication. Also, the US FDA approved nearly three times as many drugs under this pathway compared to … Read more
This week’s court ruling to deregulate the most common form of autologous stem cell therapies would allow clinics to openly offer these treatments without the fear of FDA. The court, however, only ruled in favor of the medical practice but not the marketing claims made by the providers to lure their patients to opt for … Read more
In a stunning decision against the FDA, the United States District Court for the Central District of California ruled this week that autologous fat stem cell products cannot be regulated as new drugs. The ruling contains several comments by the court that upend about two decades of FDA’s regulatory decisions and several guidance documents, that … Read more
Medical devices not approved for sale in the US can be exported to other countries provided FDA determines that such exportation is not contrary to the public health and safety, and the device has the approval of the foreign country to which it is being exported. The manufacturers of such devices need to obtain an … Read more
