Tag Archives: Janet Woodcock

PCORI Launches Clinical Research Network to Support Trials, Outcomes Research

By Jill Wechsler | Published: April 30, 2013

The new National Patient-Centered Clinical Research Network funded by the Patient-Centered Outcomes Research Institute (PCORI) aims to provide patients and clinicians with useful information on treatment options and outcomes. By encouraging more comparative clinical effectiveness research (CER), the program also has potential to support development of new drugs and devices, explained PCORI executive director Joe [...]

Posted in FDA, healthcare | Also tagged CDER, CER, Clinical Trials, comparative effectiveness, EHRs, FDA, John Castellani, outcomes, Patient Centered Outcomes Research Institute, patient information, PCORI, PhRMA, PPRMs, Sentinel | Leave a 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).

Posted in FDA, Legal, leadership | Also tagged ANDA, CDER, chemistry and manufacturing controls, CMC, generics, Office of Generic Drugs, Office of Pharmaceutical Quality, OGD, OPQ | Leave a comment

Following Industry, OPDP Hopes to Eliminate Silos in Ad Review

By Ben Comer | Published: March 8, 2013

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 – from [...]

Posted in Advertising, E-Media, FDA, Legal, Marketing, Patient Communication, Regulatory, Sales, compliance, patient education, social media | Also tagged CDER, DDMAC, OPDP | Leave a comment

Highlights from the Leerink Swann Healthcare Conference

By Ben Comer | Published: March 13, 2012

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.

Posted in Biotech, Events, FDA, Gene therapy, Strategy, Technology, leadership | Also tagged CDER, companion diagnostics, conference, DNA, FDA, genetics, Leerink Swann, Next Generation Sequencing | Leave a comment

CDER Addresses 'Challenges of Globalization' With a New Office

By Ben Comer | Published: June 8, 2011

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, Integrity [...]

Posted in FDA, Global, Regulatory, Safety, Supply Chain | Also tagged CDER, FDA | Leave a comment