ANDA Submission and GDUFA Guidance

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Presented By ComplianceOnline

Thursday, October 1st at 8:00am PST

Online sale ends: 10/01/20 at 7:00am PST

Venue to be announced shortly

2479 E. Bayshore Road Suite 260 Palo Alto, CA 94303, USA

Palo Alto, CA 94303

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Description

In addition, with the passage of GUFDA II which significantly changes the fee structure, it is also crucial to understand the major changes to the program, and the effects of those changes on the generics industry.

This webinar explains the submittal process of drugs and medicinal products and also explores the GUFDA II Guidance.

Areas Covered in the Webinar:

Overview of the ANDA and PAS processes
Overview of GDUFA
The FDA’s process for classifying major, minor, and unsolicited amendments to ANDAs or PASs.
How ANDA or PAS deficiencies that will cause the FDA to request a major amendment or classify deficiency responses as a major amendment.
The amendment format and submission process.
The FDA's review goals for amendments under GDUFA II.
How the FDA will process amendments submitted before GDUFA II.
How to request that the FDA reconsider classifying a major amendment.
A discussion of how high quality standards are maintained through inspections and risk-based approaches.
The process of and reasons for requiring the identification of the facilities involved in the manufacture of generic drugs and the associated active pharmaceutical ingredients.
The intent of the FDA to expedite product access.
How amendment submissions may affect review goal dates.

Who Will Benefit:

The audience for this webinar would consist of anyone in the generic pharma business in the following functions:

Compliance and regulatory,
Research & development,
Quality assurance. Positions would include – Director, Associate Director, Manager, and associates

Presented By

Time

8:00am to 9:00am
Doors open at 8:00am

Price

General Admission: $329.00
Purchase Using Webinar All-Access Pass: $999.00
RECORDED VERSION: $399.00
TRAINING CD / USB DRIVE: $499.00
COMBO OFFERS: $499.00
COMBO OFFERS: $599.00

Age

All Ages

Venue

Venue to be announced shortly<br> 2479 E. Bayshore Road Suite 260 Palo Alto, CA 94303, USA<br> Palo Alto, 94303

Capacity

100