FDA Reopens Debate over Major Generic Drug Labeling Rule

As Regulatory Focus has extensively reported in the past, FDA has long been interested in making it easier for all drug companies—not just innovative manufacturers—to update the safety labeling on drug products.

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FDA Reopens Debate over Major Generic Drug Labeling Rule

As Regulatory Focus has extensively reported in the past, FDA has long been interested in making it easier for all drug companies—not just innovative manufacturers—to update the safety labeling on drug products.

(more…)

SPL in eCTD

If you want to submit SPL and that too in R4 format as an original submission, it is possible.

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SPL-Prefered Substance Name

In SPL, FDA provides terminology list, which has some terms with specific codes.

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