On Friday, the SEC announced that it had adopted amendments to require electronic submission of several forms that currently may be submitted on paper and to require structured data reporting (i.e., ...

An IND application submitted to the FDA can easily run 10 or more volumes, largely consisting of reviews and copies of published studies related to the drug in question. Many of the required documents ...

CDRH has not come as far as some other FDA centers in achieving the ability to handle electronic submissions. Nonetheless, some progress is being made. Thus, device companies should stay abreast of ...

On June 3, 2022, the Securities and Exchange Commission mandated the electronic filing or submission of certain documents that reporting companies currently may provide as paper filings, by adopting ...

The Centers for Medicare and Medicaid Services on Monday put forth a new proposed rule that would modify HIPAA to better support both claims and prior authorization transactions – providing standards ...

This week, the Supreme Court updated its rules. Most attention focused on the new system to check for conflicts of interest. Merits briefs now need to include relevant stock ticker symbols for the ...

A new guidance document issued by the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) outlines a new process of submitting lot distribution reports (LDRs) ...

The Department of Homeland Security is looking for ways to automate electronic invoicing so it can process the more than 200,000 submissions it handles annually in accordance with federal requirements ...

Thanks to the FDA Reauthorization Act of 2017 (FDARA), the US Food and Drug Administration (FDA) on Wednesday published a new draft guidance with “both binding and nonbinding provisions” related to ...

Right now, 25 percent of physician claims are submitted on paper each year. That's a whopping 3 billion claims still being handled the old-fashioned way. The vast majority of those claims are being ...