Regulatory - Pharmaceutical Executive


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

"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?

Growing Pains: The European Medicines Agency at 20

February 3, 2014

Reflector looks at the growing pains of the European Medicine Agency (EMA) as it faces the key policy challenges of 2014.

Let's Modernize Post-Approval Regulation of Prescription Drugs

November 27, 2013

Let's Modernize Post-Approval Regulation of Prescription Drugs

Transparency Troubles for Pharma

November 1, 2013

High prices, murky financial relations, and a reluctance to disclose clinical data undermine public trust in industry and the research enterprise.

Supply Chain: Scanning the Future

November 1, 2013

The US and Europe are moving toward the enactment of new legislation that will change the way pharma products are handled and shipped throughout the supply chain.

Big Pharma's Newest Cost Center

October 31, 2013

As the burden of promotional disclosure expands beyond US shores, understanding the rules and then controlling the cost of compliance is a strategic necessity.

Brand-Generic Wars Heat Up

October 1, 2013

Tension mounts over biosimilars, co-pay coupons, trade, and testing.


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