FDA recently published the time-lines for the pre-approval GMP inspections for drugs and medical devices and it shows some useful time-lines for regulatory actions that may be useful to all manufacturers planning for such inspections. Prior to approval of any new drug or medical device, FDA must conduct a GMP audit of the facility where … Read more
In its latest Guidance Document and announcement for the current policy for compounding pharmacies, FDA emphasizes that the law supports only compounding drugs for which there is a clearly defined “clinical need” and not where compounded versions of approved drugs are created to make cheaper treatments for patients. The policy specifically applies to the 503B … Read more
It is assumed that greater transparency would discourage undesirable activities but experience shows that the disclosing parties become more careful and use reporting loopholes to their advantage. A review of the California law that requires companies to disclose exorbitant drug price increases seems to show little effect, if any, of such disclosure on such increases. … Read more
Earlier this year, the Associate Attorney General at the Department of Justice (DOJ) instructed its staff to not initiate civil enforcement action against any party based on Guidance Documents, a decision that can have an enormous impact on the FDA regulated industry. There are 4220 Guidance Documents available on FDA’s web site; more than a … Read more
This week FDA posted a full clinical study report (CSR) included in an NDA approved last month for prostate cancer drug ERLEADA. In this new pilot transparency program FDA plans to similarly publish CSRs for eight more newly approved drugs aiming to provide more usable information about clinical trial design, statistical analysis, and other operational … Read more
Martin Shkreli, the drug executive made infamous by his obnoxious and self-destructive behavior, got a seven year prison sentence last week. His sentence has nothing to do with the reason the country hates him, and that reason lives. He deserves the fate, many argue, but we need to thank him for exposing the ugly face … Read more
Two independent investigations by two unrelated non-profit groups show a significant number of errors on the information available on clinicaltrials.gov website regarding the status and results of the listed clinical trials. One investigation shows that about 40% of the trials that are reported to be completed and per the law should have reported their results … Read more
It seems that after about 5 years of attempts by supporters where Right-To-Try (RTT) laws were passed in about 40 states, the US Congress is getting ready to pass a Federal law that would, on paper, make experimental unproven drugs available to patients more easily. Even FDA, that has been a strong opponent of the … Read more
In an interesting development, a compounding pharmacy in Arkansas this week filed for a “Temporary Restraining Order” to prevent the FDA from shutting it down after an almost 5 years of back and forth with the FDA auditors and the company being on the verge of permanent closure by FDA. Before we run to judgment … Read more
Today FDA released an addendum to ICH E6 (R2), the GCP Guidelines, to include several provisions for quality management responsibilities of the sponsors of clinical trials. These additional requirements apply to any trials conducted under an IND or IDE and used to support a US market approval application. Some important additions include a whole section … Read more
