Tag Archives: CDER

FDA Gets More Funding, IPAB Gets Less

After two years in budget limbo, Congress finally enacted federal spending legislation for fiscal year 2014 last week, just before the latest funding extension ran out. In this period of ever-tighter government outlays, the Food and Drug Administration did fairly well in gaining additional funds, along with user fee revenues that had been put on […]
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FDA Approves Fewer New Drugs, But Acts Fast on Innovative Products

FDA Approves Fewer New Drugs, but acts fast on innovative products As expected, the Food and Drug Administration approved only 27 new molecular entities (NMEs) in 2013. There was no late-December surge in approvals to bring the tally closer to the near-record of 39 innovative new drugs approved in 2012. In addition, the Center for […]
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Frontrunners in Innovation: New Drug Approvals 2013

Frontrunners in Innovation: New Drug Approvals 2013 Trying to nail down the actual number of new drugs approvals in 2013 is like trying to swat a fly—it can be highly illusive.  Safe to say, however, as 2013 drew to a close,  the total number of new did not match 2012’s  high of 39. And yet, […]
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New Funding and Approval Pathways Prove Popular

By Rita Peters, Editorial Director, BioPharm International. Compared to other manufacturing and technology industries, the bio/pharmaceutical industry has one of the longest product development timelines. The research, development, testing, and regulatory review process typically extends for more than a decade, often exhausting the financial resources and commitment of investors. For patients with unmet medical needs, the […]
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Liability Looms for Generic Drug Safety Labeling Changes

FDA is proposing to revise its rules to permit generic drug manufacturers to initiate safety labeling changes, and not wait until the brand company takes that action. The aim of the new policy is to inform consumers more quickly of emerging safety concerns – but it also could create confusion by allowing prescribing information to […]
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