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Author Archives: Jill Wechsler
PCORI Launches Clinical Research Network to Support Trials, Outcomes Research
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 [...]
"Sunshine" Just the Tip of the Iceberg: Pharma and Full Disclosure
“Sunshine” Just the Tip of the Iceberg: Full Disclosure for Pharma:??There seems no end to demands for data on clinical research, conflicts of interest, company payments, and drug prices, writes Jill Wechsler.
Although recent legislation and regulations have greatly expanded the range of information that pharmaceutical companies have to unveil to the public, there’s an escalating [...]
Posted in Guest Blog, Op-Ed, Regulatory, Safety, Strategy, healthcare, pricing Tagged drug safety, Obamacare, regulatory affairs, Sunshine Act, transparency 1 Comment
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).
Posted in FDA, Legal, leadership 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?
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 [...]
Posted in FDA, Legal, R&D, healthcare, leadership Tagged Capitol Hill, CDC, NIH, Politics, sequestration, Sequestration Act, United States Congress, White House Leave a comment
Will Congress Provide Sequester "Flexibility" for User Fees?