Adaptive design clinical trials can give sponsor companies the flexibility to make changes to a trial in progress without compromising the validity of its findings, but also present unique challenges. Regulatory Focus spoke to experts participating...
RAPS will host a virtual workshop featuring regulators and regulatory experts on current communications guidelines and expectations for companies marketing regulated healthcare products in the US. FTC's Richard L. Cleland is among the program's featured...
The electronic Common Technical Document (eCTD) provides a common global standard for companies to electronically submit the quality, safety and efficacy information required by regulatory agencies. It is an EMA requirement and will soon be required...
Is there a Sunshine Act question you hope CMS answers before August 1st? We have been able to ask CMS those questions...
For those of you following the Centers for Medicare & Medicaid Services (CMS) implementation activities for the...
There are many parallels between reading a document for the first time and trying out a new restaurant. When you walk...
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