Neocubes Pharma Blogs

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International Recognition Procedure

International Recognition Procedure

• 21 Oct 2024
• By Neocubes pharma

e-learning

Facility Readiness-Goal Date Decisions under GDUFA

Under the Generic Drug User Fee Amendments (GDUFA), facility readiness and goal date decisions are key components of the regulatory framework governing generic drug approval processes in the United States.

• 25 Jul 2024
• By Neocubes pharma

e-learning

Content and Format of Composition in Labeling : NDA's-ANDA's

Content and Format of Composition in Labeling : NDA's-ANDA's

• 08 Jul 2024
• By Neocubes pharma

e-learning

MAPP - Generic Drug Labeling Revisions Under Section 505(j)(10) of the FFD& C Act

MAPP - Generic Drug Labeling Revisions Under Section 505(j)(10) of the FFD& C Act

• 12 Feb 2024
• By Neocubes pharma

e-learning

Portable Document Format (PDF) Specifications

Portable Document Format (PDF) Specifications

• 05 Feb 2024
• By Neocubes pharma

e-learning

One Minute Read: Suitability Petition

What is a suitability petition?

• 04 Sep 2023
• By Neocubes pharma

e-learning

Want to Learn How the User Fees are Assessed Under OMUFA?

Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program-October 2022

• 01 Sep 2023
• By Neocubes pharma

e-learning

Definition of Timely Filed Patent and Impact of Late-Listed Patent

When is any patent considered to be timely filed? What actions must a pending ANDA or 505(b)(2) applicant take if patent information is untimely filed (i.e., late-listed)?

• 25 Aug 2023
• By Neocubes pharma