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
Yesterday FDA announced that earlier this month it issued Warning Letters to four networks selling opioid drugs illegally online via 21 websites. Earlier this summer FDA had issued similar Warning letters to a total of 13 companies marketing opioid drugs illegally on about 70 websites. It is questionable if these measures are an effective deterrence … Read more
About 80% of all active pharmaceutical ingredients (API) and two-thirds of drug products sold in the US are manufactured in India and China that together boast of about 1000 FDA-registered manufacturing sites. Also, manufacturers based in the two countries hold more generic drug approvals than any other country, including the United States. One can argue … Read more
The enrollment criteria for most clinical trials exclude older or pediatric patients, patients with organ disfunctions, pregnant and lactating women, and patients with multiple chronic conditions. An FDA report released this week summarizes how data from such patient populations can be collected to support inclusion of these populations on the product labels. Sponsors are reluctant … Read more
This week FDA approved the first mobile contraceptive app created by a Swedish startup. The app basically uses a calendar connected to temperature reading submitted by the users to calculate their menstrual cycle and predict more fertile days than others. There are several reasons why this approval may be both a gimmick and a significant … Read more
A report released last month by the Clinical Trial Transformation Initiative (CTTI), a joint venture of FDA and the Duke University, contends that all clinical trials should use mobile technologies to increase patient participation and retention, while reducing cost, increasing efficiency, and capturing real-time and real-world clinical data. The report acknowledges that the sponsors will … Read more
