Tag Archives: CDER

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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Shutdown Forces FDA, HHS No-Shows

Officials from the Food and Drug Administration and the National Institutes of Health were scheduled to explain developments in clinical trial registration and transparency at the Drug Information Association’s conference on Clinical Trial Disclosure in Bethesda, Md. this week. They sent in slides, and one HHS official even pre-recorded his presentation. But the government shutdown […]
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FDA, CDER Weigh Organizational Changes

FDA commissioner Margaret Hamburg has formed a top-level working group to propose strategies for enhancing agency functions and processes, starting with the relationship between FDA Centers and its field force. The Program Alignment Group (PAG), announced Sept. 6, 2013, will seek to clarify the roles and responsibilities of product centers and the Office of Regulatory […]
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Biopharma Innovation in Trouble?

Next year it will cost $2.2 million to submit an NDA or biologics license application (BLA) for FDA review, and $1 million for a supplement with clinical data, generally to support new indications or expanded labeling. Review of a new biosimilar application that carries clinical data will be just as costly. While a $2 million […]
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