iwewlkws Traditionally, when making changes, updates or improvements to Class II devices approved under the 510k process, the developers had to file a new traditional 510k for the updated device. Under a pilot program launched earlier this week, FDA expanded the special 510 process to include most modifications of previously approved 510k devices. The special 510k … Read more
There has been a lot of criticism over the years of both FDA and NIH for not enforcing the laws for reporting clinical trial results on clinicaltrials.gov. Last week FDA announced a process for penalizing companies and individuals under the same law. It has been more than 10 years since the Food and Drug Administration … Read more
Over the last few years, FDA is increasingly refusing to meet companies, either in-person or via phone, and instead providing written responses to the applicant’s questions, a process called “Written Response Only (WRO)”. The WRO process which was originally created to make it easier to answer routine questions in certain meeting requests is now being … Read more
FDA has declared sort-of an all-out war on e-cigarettes citing increased use by adolescents and young adults with hundreds of Warning Letters and threats of punitive actions. There is no argument that children should not be smoking but by expanding the definition of smoking to include inhaling essentially water vapor mixed with pure nicotine, it … Read more
This week FDA released an educational guidance for prescribers of opioid drugs intended to limit opioid prescription through increased diligence by the physicians. The FDA guidance is very similar to that from CDC released last year for the same purpose. Most of the patients get opioid drugs via prescriptions from their physicians, hence the best … Read more
In a detailed report of the current practices for application review by FDA, the Office of Inspector General (OIG), Department of Health and Human Services, recommended FDA take additional steps to assure that medical devices are protected from cybersecurity issues. These include having sponsors discuss cybersecurity issues at pre-submission meetings, adding cybersecurity assessment in the … Read more
This week FDA proposed a change to the medical device submission rules whereby all 510k, IDE and PMA submissions will only be accepted electronically; paper copies will no longer be accepted. Since 2013, FDA has accepted eCopies of the paper submission. The applicants were required to prepare at least one fully compiled printed copy of … Read more
For the last few years, FDA has allowed device manufacturers to utilize the Parallel Review Program whereby the manufacturers can have both FDA and CMS review the clinical evidence at the same time in support of both the approval by FDA and the coverage by CMS of a new medical device. This week FDA announced … Read more
It is no secret that FDA cannot inspect all drug manufacturing sites, so it prioritizes certain kind of sites based on internal selection criteria. But till yesterday, the details of the selection process were not publicly known. Yesterday FDA released its internal policy for selecting and prioritizing drug manufacturing sites for inspections providing a new … Read more
This week FDA announced a new initiative to encourage disruptive clinical trial designs aiming to expedite market approval of promising drugs and biologics. Several of these trial designs have been proposed in the recent years, mostly for products intended to treat cancers. The new initiative, called Complex Innovative Trial Design (CID) expands innovative trial designs … Read more
