Regulatory

Jul 09, 2018
Raman Sehgal talks to three industry leaders for their insights on the challenges faced across the life science sector and how the EMA needs to respond.
Jul 07, 2018
Pharmaceutical Executive
Streamlined clinical research, more guidance speed new cures to patients. Jill Wechsler reports.
Jul 02, 2018
Jill Wechsler details recent bipartisan action to support treatment of opioid abusers and deter inappropriate drug prescribing and illegal distribution.
Jun 25, 2018
FDA has finalized a more flexible policy for how biopharma companies discuss payments, outcomes, and healthcare economic data with payers, formulary committees, and other audiences with expertise in drug prescribing and coverage.
Jun 25, 2018
Steve Gens talks to Pharm Exec about the evolution of Regulatory Information Management (RIM) and offers some predictions for 2022.
Jun 20, 2018
Legislators have requested that FDA do more to prevent drug shortages.
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.
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