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The National Advertising Division (NAD) of the Better Business Bureau (BBB) recently reminded advertisers that tout the benefits and health-related features of their products to be mindful of the Federal Trade Commission’s...more
Two organizations representing research institutions and integrity officials have called for a virtual rewrite of the regulations that govern misconduct in Public Health Service-funded studies. The Association of Research...more
Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of...more
On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” ...more
In March of this year, the State Council released the Scientific Data Administrative Measures, a set of rules with the seemingly innocuous aim of collecting and making public the results of government-funded scientific...more
Below are some recent regulatory developments in the biologics space. As we previously reported, USP has been considering a revision to the naming conventions for the titles of biologics product monographs. ...more
The updates to the Common Rule, effective January 19, 2018, make some significant changes of which those involved in government-funded clinical research involving human subjects should be aware. These changes include...more
The following day features a panel of chief executive officers from a variety of pharmaceutical companies of different sizes and focus areas. Common themes included ongoing industry consolidation and increasing concern about...more