Last week FDA announced that it is modernizing multiple aspects of its review processes in an effort to make quick decisions, work collaboratively with sponsors and take patient perspectives into consideration for clinical trial design and market approval decisions. To provide examples of its new approach FDA released five new Guidance Documents for neurological disorders … Read more
Sponsors looking to get semi-formal advice from FDA regarding which laws apply to their product; drug, device or biologic, got some help from FDA last week with the release of a new guidance about the pre-request for designation (pre-RFD) process. The RFD process that has been in existence for 15 years is run by the … Read more
This week FDA finalized a rule originally proposed exactly five years ago to the date that makes it mandatory for all clinical trials conducted with new medical devices to be compliant with GCP rules similar to those for drugs and biologics. Although the notification refers to non-US clinical trials, but the details of the rule … Read more
FDA commissioner released a list of priorities for this year that could be categorized into two broad areas: encourage domestic manufacturing, and increase the role of real world evidence (RWE) for product approval. To boost domestic manufacturing, FDA plans to focus its attention of new technologies, particularly for biotechnology products and medical devices. FDA will … Read more
A doctor with competing interests complained that a NIH-funded study similar to his earlier trial was unethical because it involved giving placebo to children. This prompted NIH to call an urgent meeting of the DSMB for the placebo-controlled trial and some changes to the trial to address the concerns. However, this case points to some … Read more
Drug companies openly sell unapproved antibiotic combinations in India creating a terrifying scenario of prevalence of multidrug resistant bacteria creating incurable infections. There have been several reported cases of the multidrug resistant bacteria infecting travelers bringing the infections to other countries worldwide. According to research study published this week in the British Journal of Clinical … Read more
Cell phones emit Radiofrequency Radiations (RFR), a kind of non-ionizing radiations, which have been suspected to causing cancer with frequent use. Last Friday, the National Toxicology Program (NTP) published preliminary results of its two year carcinogenicity study with cell phone radiation that led to a simultaneous news release by FDA trying to play down the … Read more
Three states, Mississippi, Missouri and Colorado recently proposed bills to allow off-label promotion of drugs. These states are following on the lead established by Arizona that passed a law last March to allow drug companies to legally promote off-label uses of FDA-approved products (drugs, biologics and medical devices) without any fear of prosecution by the … Read more
Negative FDA audits could have catastrophic consequences for the companies at the receiving end. It could lead to drastic financial losses, loss of credibility and even push the defaulter out of business. If a company is destroyed by a negative FDA audit, can it sue FDA for damages? Can a company successfully claim that the … Read more
In his response to a GAO report that FDA needs to evaluate appropriate implementation of the least burdensome requirements of the 21st Century Cures Act, the FDA Commissioner announced that FDA has already trained more than 90 percent of its reviewers in CDRH in least burdensome requirements for new medical device approval decisions, and that … Read more
