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eCTD/CTD/NeeS Publishing solution
  • Home
  • About us
    • Company Overview
    • Testimonials
  • Services
    • Overview
    • Regulatory submissions
      • eCTD
      • Drug Master File (DMF)
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      • NeeS
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    • Regulatory services
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Category: SPL and SPL R4

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SPL and SPL R4
_ June 23, 2015_ KnetAdmin_ 0 Comments

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.

LEARN MORE ♥27
SPL and SPL R4
_ April 6, 2010_ KnetAdmin_ 0 Comments

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 and SPL R4
_ January 20, 2010_ KnetAdmin_ 0 Comments

SPL-Prefered Substance Name

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

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