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
FDA is working on new rules to require a simplified one-page Medication Guide for prescription drugs to supplement the longer package inserts that usually accompany a drug to make it easier for the patients to understand their medication. Earlier this week FDA announced its major policy goals for this year and it contains several things … Read more
FDA released a new guidance to describe the current process for arranging meetings with the review divisions in CDER ad CBER combining and simplifying information from previous guidance documents, updating some critical timelines and retiring the old defunct guidance documents on the same topic. In the last decade, FDA’s management carried out a major publicity … Read more
Last year FDA conducted 17,487 audits worldwide, and issued 5045 FDA 483s, meaning that about 30% of the audits lead to non-compliance in more than one regulated area. There were 498 Warning Letters issues during the same time showing that 1 in 10 audits found repeat violations that required more serious enforcement action by FDA. … Read more
FDA would like developers of new medical devices do fewer clinical trials, use clinical trial data from outside the US, rely on data from uncontrolled open-label studies, and use unconventional data to support PMA and 510k applications. Manufacturers should try to “use the minimum amount of information necessary to adequately address a regulatory question or … Read more
