Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What is the Agency’s position on using different lots of APIs and/or packaging materials? How many API lots should be used in the manufacture of finished product lots used to support the ANDA? 1.60K viewsFDA 0 Votes 1 Ans Should the small scale batches be packaged with commercial equipment? Also, is it acceptable to package using research equipment or by hand? 1.81K viewsFDA 0 Votes 1 Ans What will the recommendation for secondary packaging be? 1.81K viewsFDA 0 Votes 1 Ans What are the recommendations for stability testing data of modified release dosage forms? 1.58K viewsFDA 0 Votes 1 Ans What are the recommendations for the submission of oral solutions, ophthalmic solutions, oral and ophthalmic suspensions, transdermal patches, ointments, creams, granules for reconstitution, and parenterals? 1.76K viewsFDA 0 Votes 1 Ans Are 6 months of stability data required on all three batches, or would one batch at 6 months and two lots at 3 months be acceptable? 1.49K viewsFDA 0 Votes 1 Ans Does all relevant CMC batch information for the three stability batches need to be included in the application? 1.76K viewsFDA 0 Votes 1 Ans If you are an applicant submitting an ANDA with two API sources, are you required to perform stability on three batches of drug product for each API source? 1.67K viewsFDA 0 Votes 1 Ans What is meant by “small” scale? “Small” is not a defined word in ICH guidance. What are the packaging expectations from the small batch, as well as from the two pilot scale batches? Traditionally, ANDAs are submitted with 100,000 units for solid oral dosage forms. Is this still applicable? 1.80K viewsFDA 0 Votes 1 Ans Is it acceptable to use a technical grade of the drug substance for the small scale batches or one of the two pilot scale batches of finished drug product? 1.78K viewsFDA 0 Votes 1 Ans How will this guidance affect the President’s Emergency Plan for AIDS Relief (PEPFAR) and positron emission tomography (PET) ANDAs? 1.58K viewsFDA 0 Votes 1 Ans Can an ANDA be submitted with 6 months of accelerated stability and 6 months of long-term stability data? 1.72K viewsFDA 0 Votes 1 Ans When do intermediate stability studies need to be initiated in the event of failure at accelerated condition? 1.92K viewsFDA 0 Votes 1 Ans If one among the three batches in accelerated conditions shows a significant change, what should be done? 1.72K viewsFDA 0 Votes 1 Ans Can stability bracketing and/or matrixing be used to determine the packaging configurations to be placed on stability for an original ANDA without prior approval from the Office of Generic Drugs (OGD)? 1.67K viewsFDA 0 Votes 1 Ans During the review cycle, will the application need to be updated with 12 months of long-term data? 1.73K viewsFDA 0 Votes 1 Ans Can only two lots of finished product at pilot scale batch size ever be considered sufficient to support the stability of an ANDA for simple dosage forms? 1.78K viewsFDA 0 Votes 1 Ans How is the proposed shelf life supposed to be calculated? Will 6 months of accelerated data equal 24 months at long-term? 1.73K viewsFDA 0 Votes 1 Ans Will the recommendation for 6 months accelerated data be met by providing 24 weeks of data as 12 weeks is typically accepted as equivalent to 3 months? 1.93K viewsFDA 0 Votes 1 Ans When a patent is due to shortly expire and there are no approved ANDAs, can we file with 3 months stability data with a commitment to supply 6 months data when available? 1.62K viewsFDA « Previous 1 2 … 142 143 144 145 146 … 283 284 Next » Question and answer is powered by anspress.net
