Regulatory

Nov 09, 2016
The surprise victory of Donald Trump opens the door to new strategies for providing healthcare to Americans, including coverage and oversight of prescription drugs.
Nov 02, 2016
Policymakers, payers and pharma companies weigh strategies for rationalizing drug prices
. Jill Wechsler reports.
Nov 02, 2016
FDA officials agree that large comparative clinical trials defeat the purpose of the abbreviated development program for biosimilars.
Oct 27, 2016
The FDA approved Sarepta’s Exondys for Duchenne muscular dystrophy despite little evidence of efficacy.
Oct 24, 2016
FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.
Oct 07, 2016
Despite notable deficiencies in the frameworks for assessing the value of prescription drugs, these initiatives are expected to have a major impact on drug utilization and reimbursement.
Sep 28, 2016
ISPOR's Value Assessment Stakeholder Conference showed its Special Task Force still reaching for clarification around the subject, writes Ansis Helmanis.
Sep 28, 2016
The EpiPen eruption plus the emergence of more cutting-edge therapies with drug and biotech components has put combination products under the spotlight. Jill Wechsler reports.
Sep 26, 2016
PDUFA VI to enhance FDA staffing, revise fees and expand evidence for drug development.
Sep 22, 2016
The UK is moving closer to aligning its two approaches to regulating drug pricing — the voluntary PPRS and statutory price cuts — but the headaches are likely to continue, writes Leela Barham.
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