Day: August 20, 2020

FDA published a guidance this week about its on-site inspection policies during the pandemic which all but confirms that it is not planning to conduct any foreign on-site inspections and few, if any, domestic on-site inspections, till at least the rest of the year and possible into the first quarter of next year. FDA will … Read more

After years of hesitating to enforce the clinical trial reporting requirements, this week FDA released its guidance on penalties for non-compliance with clinicaltrials.gov posting rule. It satisfies the critics of the non-enforcement but at the same time gives a huge break to the current violators by wiping the slate clean and restarting the clock, in … Read more