Tag Archives: Janet Woodcock

CDER Runs into Trouble with Generic Drug Reorg Plan

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).
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Following Industry, OPDP Hopes to Eliminate Silos in Ad Review

The Office of Prescription Drug Promotion (OPDP) is reorganizing its two primary advertising review divisions – professional and consumer – in an attempt to stay in line with the silo-breaking, multi-channel promotional output pouring in from pharma. The line between physician marketing and consumer marketing has blurred as the facets of a brand campaign – […]
Posted in Advertising, compliance, E-Media, FDA, Legal, Marketing, Patient Communication, patient education, Regulatory, Sales, social media | Also tagged , , | Leave a comment

Highlights from the Leerink Swann Healthcare Conference

Over a hundred public companies, dozens of clinicians, and several regulators participated in investment firm Leerink Swann’s 2012 Healthcare Conference in mid-February. Press was barred from the event, but John Sullivan, Leerink’s director of research, gives PharmExec a few of the take-aways.
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CDER Addresses 'Challenges of Globalization' With a New Office

In recognition of the difficulties presented by a rapidly expanding global drug market, FDA’s Center for Drug Evaluation and Research (CDER) has created a new office “dedicated to addressing the challenges of globalization and an increasingly complex drug supply chain,” according to memo sent by CDER director Janet Woodcock. The new “Office of Drug Security, […]
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Industry and FDA Brace for Change

While the convention floor of the 46th annual meeting of the Drug Information Association bustled with the usual vendors touting the latest and greatest clinical trial technology, the panels (particularly those that featured FDA members) had a remarkably somber tone. The main refrain was: “Things are going to change and everyone must step up or […]
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