Regulatory

Jan 10, 2018
If confirmed as the next secretary of the Department of Health and Human Services (HHS), Alex Azar says that a top priority is to make drugs more affordable.
Dec 31, 2017
Enacting landmark tax reform legislation that makes major changes in the corporate tax structure was Congress's Christmas present to President Trump — and to industry, writes Jill Wechsler.
Nov 30, 2017
Experts slam drug prices and endorse government price negotiations and curbs on drug advertising.
Nov 27, 2017
Halfway through the process for establishing a national electronic drug tracking system, there’s concern among pharma companies, distributors, and pharmacists about meeting the 2023 deadline
Nov 22, 2017
Jill Wechsler discusses the hot topic of how FDA should oversee combination products that incorporate a digital health component.
Nov 20, 2017
While the GAIN Act's Qualified Infectious Disease Product (QIDP) designation program has been successful in driving innovation, commercial viability remains a question.
Nov 07, 2017
While most pharma companies are in partial production using generators, few are operating at 100% capacity, writes Jill Wechsler.
Nov 07, 2017
Despite FDA approval of seven biosimilars through October 2017, only three have come to market, fueling concerns about the safety of switching patients to new therapies.
Nov 03, 2017
Pharmaceutical Executive
Agency leaders go slow in weighing changes to DTC ads and off-label marketing. Jill Wechsler reports.
Oct 11, 2017
Pharmaceutical Executive
FDA seeks to de-risk research and promote competition to achieve savings for patients and plans.
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