Learn about the technical documentation manufacturers must prepare before placing a product on the EU market. This includes ...

Drug approval is the goal of the long process of drug development. Once preclinical and clinical trial data have been collected, a New Drug Application must be submitted to the regulatory authority ...

EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document ...

MELVILLE, N.Y. — October 17, 2016 — Canon U.S.A., Inc., a leader in digital imaging solutions, today announced the launch of the new Océ PlotWave 550 wide-format monochrome printing system, the newest ...

The US Food and Drug Administration finalized a Guidance for Industry this week that aims to clarify the submission of new drug applications (NDAs) and biologics license applicants (BLAs) using the ...

Martin LaMonica is a senior writer covering green tech and cutting-edge technologies. He joined CNET in 2002 to cover enterprise IT and Web development and was previously executive editor of IT ...

Checking up occasionally on your writing skills is a good idea. Why? Much of our communication today consists of emails and texts. I don’t know anyone who would say communication isn’t important. If ...