Category Archives: leadership

FDA: From Risk Aversion to Approval Activism

By Ben Comer | Published: May 7, 2013

During the Rutgers Business School’s annual healthcare symposium, an FDA official encouraged industry to put its drugs on the reviewing table and be prepared for good news. On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based [...]

Also posted in Agency Insight, Biotech, FDA, Legal, Market Access, Orphan Drugs, People, R&D, Regulatory, Strategy | Tagged access, breakthrough therapies, CDER, Cole Werble, FDA, IMS, Rachel Sherman, Regulatory | 2 Comments

Ad Agency Encourages Pharma Marketers to Reboot

By Ben Comer | Published: April 16, 2013

People tell you who they are, but we ignore it – because we want them to be who we want them to be. – Don Draper At the beginning of the Reboot Camp – held at New York City’s Alexandria Center on April 12 – Intouch Solutions’ CEO Faruk Capan declared the days of Don Draper [...]

Also posted in Advertising, Agency Insight, Emerging Markets, FDA, Marketing, Patient Communication, People, Regulatory, Sales, Strategy, Technology, healthcare, patient education, social media | Tagged Agency, big data, Crossix, digital health, digital marketing, Fitbit, FuelBand, GE Healthcare, Happtique, Intouch Solutions, mHealth, mobile health, Sanofi | 1 Comment

CDER Runs into Trouble with Generic Drug Reorg Plan

By Jill Wechsler | Published: March 15, 2013

After less than a year on the job, the head of FDA’s Office of Generic Drugs (OGD) has announced his departure, a sign that all is not well with plans for major organizational changes at the Center for Drug Evaluation and Research (CDER).

Also posted in FDA, Legal | Tagged ANDA, CDER, chemistry and manufacturing controls, CMC, generics, Janet Woodcock, Office of Generic Drugs, Office of Pharmaceutical Quality, OGD, OPQ | Leave a comment

Sequestration: How Big a Hit for FDA, Research and Pharma?

By Jill Wechsler | Published: March 12, 2013

The greatly feared federal budget sequestration mandate went into effect March 1, and, initially, the impact was fairly muted. The stock market soared, employment rose and government workers continued on their jobs. Federal agencies, including the Food and Drug Administration (FDA), launched initiatives to comply with the mandated 5% across-the-board cut in spending (in reality [...]

Also posted in FDA, Legal, R&D, healthcare | Tagged Capitol Hill, CDC, NIH, Politics, sequestration, Sequestration Act, United States Congress, White House | Leave a comment

State Surprises as Obamacare Starts Up

By Guest Blogger | Published: February 1, 2013

by Tom Norton This past week or so, with Obamacare’s start up less than a year away, we have been treated to several entertaining vignettes as the nation’s governors begin to wrestle with the realities of the new healthcare law.

Also posted in Guest Blog, Legal, Strategy, healthcare | Tagged ACA, health exchanges, Health Reform, HHS, Kathleen Sebelius, Medicaid, Medicare, Obamacare, States | Leave a comment