Regulatory

Aug 10, 2018
New Action Plan aims to streamline development, but rebates and reimbursement block market access.
Aug 07, 2018
Pharmaceutical Executive
Recent bipartisan efforts look to expand access for addiction treatment and stem inappropriate drug prescribing.
Jul 27, 2018
Artificial intelligence adoption by pharma companies in the UK demands a new, agile governance layer, write Tim Wright and Antony Bott.
Jul 25, 2018
Scott Gottlieb is proposing to flatten out FDA’s structure by having Center directors report directly to him, giving more authority to the agency’s six product regulatory Centers and to the Office of Regulatory Affairs.
Jul 20, 2018
Rising pressure to access less expensive prescription medicines available overseas is prompting the Trump administration to explore flexible import policies, reports Jill Wechsler.
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.
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