Regulatory - Pharmaceutical Executive

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Regulatory
New developments and strategies for success in dealing with FDA, OIG, SEC, EMEA, and more.

"Sunshine" Goes Live — Despite Incomplete Information

October 1, 2014

The federal Open Payments program has gone live, even though 40% of the data is "de-identified". Biopharma companies continue to be concerned about the lack of context, writes Jill Wechsler.

Eruptions on Europe's Drug-Pricing Horizon

September 22, 2014

The EU may have a new monitoring scheme for Iceland's volatile geology, but it should also heed the volcano that could blow apart its assumptions on drug pricing and reimbursement, says Reflector.

Pharma Battles Hospitals Over Discount Pricing Program

September 3, 2014

Continued growth in a program that provides low-cost drugs to safety-net hospitals has sparked "trench warfare" over which medicines and providers are eligible for the discounts, writes Jill Wechsler.

Europe Gears Up to Attack Counterfeit Medicines—But Only Some of Them

July 1, 2014

Cross-sector partnership seeks support for a pan-European system to keep fake drugs out, but obstacles are many.

Compassionate Use Requests Complicate Drug Development

June 1, 2014

Pharma, HCPs, and regulators walk tightrope in addressing early-access push while supporting biomedical R&D.

Rebuilding European Pharma's Competitive Agenda

May 19, 2014

Because of the tougher conditions they face and shifts in ownership and corporate strategy, EFPIA and EGA have started to work together much more closely.

"Market-Based" Price Controls In India?

April 1, 2014

Three strategic implications for pharma pricing strategies in India.

Manufacturers Struggle with FDA's "Breakthrough Drug" Development

March 21, 2014

Accelerated testing and production create challenges in documenting product quality, writes Jill Wechsler.

The Affordable Care Act's Impact on Innovation in Biopharma

February 14, 2014

How will the biopharmaceutical industry contemplate product innovation in the changing landscape of US healthcare?

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