Regulatory

Jun 14, 2018
Ilyssa Levins talks to Pharm Exec about some of the regulatory, compliance and legal challenges posed by the digital health revolution.
Jun 10, 2018
Pharmaceutical Executive
There is no magic bullet that will dramatically impact drug pricing to everybody’s liking. But a stepwise approach involving a series of reforms, including taking advantage of the next midterm elections, could point the path toward a solution.
Jun 07, 2018
Pressure to assess and approve a growing volume of promising new drugs and biologics in accelerated timeframes is prompting a major reorganization of CDER's Office of New Drugs.
Jun 01, 2018
Structured authoring is an approach that has eluded life sciences, limiting firms’ ability to transform routine regulatory processes. But this could all change, writes Romuald Braun.
May 23, 2018
Right-to-Try bill sent to White House for President’s signature after passage by Congress.
May 15, 2018
As submissions complexity intensifies, the key to better resource management is better measurement, writes Adrian Leibert.
May 14, 2018
After months of expectations and repeated delays, President Trump formally announced his strategy for making prescription medicines more affordable and accessible in the U.S.
May 11, 2018
Ashley Slavik outlines the preparations for the new EU data protection regulation, and what others can learn from the experience
May 09, 2018
Pharmaceutical Executive
Pharm Exec interviews the FDA commissioner, who is building support by combating opioid abuse and advancing innovation.
May 02, 2018
From BioPharm International
Public health authorities and the biomedical research community are seeking new strategies to address global health threats, writes Jill Wechsler.
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