Regulatory

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.
Aug 29, 2017
With a new consultation from the UK’s Department of Health proposing changes to the Statutory Scheme for Pricing of Branded Medicines, what could this mean for negotiation of a successor to the Pharmaceutical Price Regulation Scheme? Leela Barham reports.
Aug 28, 2017
A long list of high priority issues requiring immediate attention on Capitol Hill leaves little time to consider drug access proposals that have limited bipartisan support, writes Jill Wechsler.
Aug 28, 2017
The federal Open Payments program is finally reaching its goal—to halt the adoption of multiple “transparency” initiatives. But will it make a difference, asks Jill Wechsler.
Aug 07, 2017
Jill Wechsler on the Senate's 94-1 vote to approve legislation reauthorizing user fees and a series of program changes to maintain a smoothly functioning FDA product review and approval process.
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