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Category Archives: FDA
Refilling the Antibiotic Pipeline: How to Lead the Horse to Water?
Last week, the United States Center for Disease Control (CDC) and Britain’s Chief Medical Officer issued separate warnings about the urgent problem of antibiotic resistance in infectious diseases. Given industry’s general lack of interest in developing new antibiotics to address this problem, the warnings indicate that a discussion is needed around which incentives and regulatory [...]
Also posted in Global, Market Access, R&D, Regulatory, Safety, Strategy, pricing Tagged Antibiotics, CDC, GAIN Act, IDSA, LPAD 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).
Also posted in 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 [...]
Also posted in Legal, R&D, healthcare, leadership Tagged Capitol Hill, CDC, NIH, Politics, sequestration, Sequestration Act, United States Congress, White House Leave a comment
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