Regulatory

Nov 20, 2017
The GAIN Act creates a process for the Qualified Infectious Disease Product (QIDP) designation, which provides incentives for developing antimicrobial therapies for combating resistant organisms. But while the 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.
Oct 10, 2017
FDA is evaluating whether limiting warnings in TV commercials to the most serious adverse effects might be more informative for consumers than the current laundry lists of potential side effects.
Oct 05, 2017
The extensive volume of pharmaceutical manufacturing in Puerto Rico is driving FDA efforts to assess facility damage and logistical problems to ensure continued supply of critical medicines. Jill Wechsler reports.
Sep 25, 2017
While biopharma companies have pressed hard for clarity on the data required to gain market approval of biosimilars that can be filled by a pharmacist without prescriber pre-approval, the progress towards "interchangeability" has been slow. Jill Wechsler reports.
Sep 21, 2017
Pharmaceutical Executive
Despite delay in enforcement of Drug Supply Chain Security Act's new serialization requirement, getting compliant now is key.
Sep 05, 2017
Pharmaceutical Executive
Drug pricing, right-to-try, opioids, and OTC improvements still on legislative agenda. Jill Wechsler reports.
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