Regulatory

Sep 21, 2018
Dan Rubin discusses how a full-service prior authorization (PA) support program facilitates higher PA submission rates and more prescriptions dispensed.
Sep 20, 2018
FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies and reimbursement strategies to support innovative new medicines to combat infectious diseases.
Sep 10, 2018
With the rise in industry programs for developing biosimilars, tensions are high as innovator firms back strategies that appear designed to delay competition. Jill Wechsler reports.
Aug 29, 2018
A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.
Aug 28, 2018
The Senate has approved several multi-agency budget bills for the coming fiscal year that boost funding for FDA and the NIH – and include a contentious provision that requires biopharma companies to disclose product prices in direct-to consumer advertising.
Aug 24, 2018
A recently announced collaboration between EUnetHTA, WHO, and ISPOR brings home the fact that there is still no real agreement on a definition of HTA, writes Reflector.
Aug 23, 2018
Just as biopharma companies are mastering the complexities of the five-year-old federal Open Payments program, state governments are enacting a host of additional marketing and disclosure rules and restrictions on industry interactions with HCPs.
Aug 20, 2018
Pharmaceutical Executive
While digital transformation in life sciences starts with digitization for compliance, it should be seen as a key lever of competitive advantage and success, writes Jaleel Shujath.
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.
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