Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

NDA AND ANDA QUALITY ASSESSMENT PILOT PROGRAMS

This article was originally published in The Gold Sheet

Executive Summary

...are being launched that will help transform the way CMC information is submitted and reviewed in the U.S. The new NDA and ANDA pilots are intended to better focus CMC reviews on the design, development and manufacturing science behind quality, resulting in more effective and efficient regulatory and manufacturing processes. On the NDA side, FDA’s Office of New Drug Chemistry intends to work hand in hand with volunteer companies in developing and clearing a dozen applications that will embody the principles of quality by design, product knowledge and process understanding central to the new regulatory paradigm. The Office of Generic Drugs, meanwhile, is launching an ANDA "question-based review" model that will drive both applicants and reviewers to focus directly on what is most critical to the quality assessment process. The pilots will be accompanied by a workshop in early October to debate the relevant challenges and issues and help target the new CMC review procedures and guidance.

You may also be interested in...



FDA Warns Generics Firms About January QbD Deadline for ANDAs

Come January, if there is no quality target product profile (QTPP) in an abbreviated new drug application (ANDA), FDA might not file it, agency officials told a Generic Pharmaceutical Association workshop. Even though quality by design (QbD) remains optional for brand drugs, it will be expected for generics, said Office of Generic Drugs representatives who went on to outline pending question-based-review (QbR) revisions designed to elicit QbD information.

ANDA Deficiencies Persist Despite QbR; Reviews to Focus More on Excipients

Despite full adoption of question-based review in the generic drug industry, some of the chemistry and bioequivalence issues QbR was meant to help resolve have persisted, say officials from FDA’s Office of Generic Drugs.

ANDA Deficiencies Persist Despite QbR; Reviews to Focus More on Excipients

Despite full adoption of question-based review in the generic drug industry, some of the chemistry and bioequivalence issues QbR was meant to help resolve have persisted, say officials from FDA’s Office of Generic Drugs.
UsernamePublicRestriction

Register

PS000075

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel