Newsletter - August 20, 2020
Violators of Clinicaltrials.gov Requirements Given a Break by FDA
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...Read More
FDA To Continue Remote Audits At Least Through The Rest of the Year
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....Read More
Violators of Clinicaltrials.gov Requirements Given a Break by FDA
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...Read More
FDA To Continue Remote Audits At Least Through The Rest of the Year
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....Read More
