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Regulatory

Sep 13, 2019
Time is running out on Ned Sharpless’ term as FDA acting commissioner, generating much talk as the administration shows interest in naming a new head for the agency.
Sep 10, 2019
Pharmaceutical Executive
Market consolidation limits sales, while legal challenges offset regulatory gains.
Sep 05, 2019
As part of the Open Payments program expansion, drug and medical device manufacturers will have to report payments and other “transfers of value” to a broader range of health professionals.
Sep 03, 2019
Patients, clinicians, pharmacists and the wider public should be front of mind when evaluating priorities and steps towards Identification of Medicinal Products (IMDP) and other emerging standards, writes Frits Stulp.
Sep 03, 2019
Jill Wechsler casts her eye over the multitude of health reform measures emerging on Capitol Hill.
Aug 27, 2019
Every big shift will stir up dissenters, but these negative forces can actually offer a useful contribution and could make all the difference in regulatory information management transformation, writes Steve Gens.
Aug 20, 2019
Pharmaceutical Executive
By Lisa Henderson
In a sit-down with editors from our group publications, former FDA Commissioner Scott Gottlieb chatted with Pharm Exec on several topics, including the evolution of pricing and reimbursement for novel therapies—and the access fixes needed for future.
Aug 16, 2019
Ben Jacoby looks at the potential for disruption caused by major changes in medical-device transparency and traceability requirements, and offers a practical response.
Aug 08, 2019
Pharmaceutical Executive
Agency focused on advancing testing and production methods, seeking input from other regions on common approaches.
Aug 08, 2019
HHS, FDA back Trump back cheaper foreign drugs to cut pharma costs. Jill Wechsler reports.
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