The US Food and Drug Administration (FDA) has issued final guidance outlining the agency’s review goals for amendments to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) under Generic Drug User Fee Amendments II (GDUFA II).
FDA issues final guidance on ANDA/PAS amendments
Home/Guidelines | Posted 31/08/2018 0 Post your comment
GDUFA provides extra funds for the FDA via the collection of fees from generics’ makers and active pharmaceutical ingredient manufacturers. GDUFA II was signed into law on 18 August 2017 in order to facilitate timely access to quality, affordable generics.
ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA
Date: July 2018
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm404440.pdf
Under the new system, FDA has committed to review and act on 90% of standard major ANDA amendments within 8 months of submission if the agency does not require a pre-approval inspection. In cases where an inspection is necessary, the timeline will be 10 months.
For priority major ANDA amendments, the agency will review and act on 90% within 6 months in cases where pre-approval inspection is not required. In cases where an inspection is necessary, the timeline will be 8 months. The agency has also committed to review and act on 90% of standard and priority minor ANDA amendments within 3 months of submission.
For PAS amendments, FDA will review and act on 90% of standard major PAS amendments within 6 months (no pre-approval inspection) and within 10 months (with pre-approval inspection) of submission. For priority major PAS amendments, the agency will review and act on 90% within 4 months (no pre-approval inspection) and within 8 months (with pre-approval inspection). For standard and priority minor PAS amendments, the FDA will review and act on 90% within 3 months of submission.
The guidance finalizes the October 2017 draft guidance for industry ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA.
Related article
FDA and industry agree on terms of GDUFA II reauthorization
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.
Source: FDA
Policies & Legislation
Strategic plans of ANVISA and COFEPRIS to advance health regulation
Panama enacts new bill to guarantees the supply of medicines
Reports
Follow-on biological/biosimilar approvals in Latin America by therapeutic class
Follow-on biological/biosimilar approvals landscape in Latin America
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Related content
New decree for the prescription and commercialization of medicines in Argentina
FDA issues draft guidance on biosimilars and interchangeable biosimilars labelling
WHO’s revised guideline to safe and effective biosimilar products
New FDA guidance on statistical approaches to establishing bioequivalence
Comments (0)
Post your comment