ASPHALION | REGULATORY AFFAIRS SUMMER QUIZ

July 1, 2024

Test your Regulatory knowledge!! 

The summer is back and, for a 4th year in a row, so is Asphalion’s classic ASPHAQUIZ on LinkedIn, our daily quiz to see how much our followers know about Regulatory Affairs.  

We will publish a daily poll, Monday to Friday. The results of today´s poll will be published the next day with a new challenge. Don´t miss it! 

We hope you will enjoy it! Do not hesitate to share, comment and participate! 

Check it out at our LinkedIn daily throughout July and August: ASPHAQUIZ

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NEWS | Update from FDA

This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that will be referenced in an abbreviated new drug application (ANDA), or a prior approval supplement (PAS) to an ANDA. This guidance explains how FDA incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA), as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023- 2027” (GDUFA III commitment letter). Specifically, this guidance describes instances when an early assessment or “DMF prior assessment,” could be requested by a DMF holder and the circumstances under which FDA would commence an early assessment of Type II API DMFs 6 months prior to an ANDA or PAS submission referencing the DMF. It also provides recommendations for such DMF holders when making a request. The guidance does not apply to Type II API DMFs used to support new drug applications (NDAs), submissions related to ANDAs that are not described above, or any other types of DMFs.

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