We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The process for institutional review boards (IRBs) to refer potentially high-risk clinical trials involving children to the FDA for special review is laid out in detail in a new guidance document.
The FDA is pledging to continue fighting an effort by wholesalers to stop the agency from implementing its drug-tracking rule, despite early setbacks in court.
Device clinical trial sponsors will be subject to new requirements under FDA draft guidance on the format, content and review of reports related to clinical postapproval studies.
The process for institutional review boards (IRBs) to refer potentially high-risk clinical trials involving children to the FDA for special review is laid out in detail in a new guidance document.
The SEC will soon issue guidance laying out a more flexible approach to meeting Sarbanes-Oxley (SOX) reporting and auditing requirements, easing the burdens on smaller companies.
The SEC will soon issue guidance laying out a more flexible approach to meeting Sarbanes-Oxley (SOX) reporting and auditing requirements, easing the burdens on smaller companies.
The FDA intends to issue a proposed rule on cGMPs for combination products next spring, a senior FDA official said at the Regulatory Affairs Professionals Society annual conference last month. Read More
The U.S. FDA has revised industry guidance on device tracking, noting that manufacturers are not required to track devices unless the agency has issued them an order to do so. Read More
The U.S. FDA has issued a draft guidance to help absorbable hemostatic device manufacturers prepare 510(k)s, following the reclassification of such devices as Class II special controls. Read More