FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans For sterile products, is it acceptable to manufacture the small scale batches in a nonsterile facility and allow variance from sterility and particulate criteria? 1.54K viewsFDA 0 Votes 1 Ans Should small scale batches be produced at the proposed commercial site? 1.60K viewsFDA 0 Votes 1 Ans In cases where an intermediate bulk material is identical between the various strengths (dose proportional blends, bulk solutions, etc.), is it sufficient to perform stability on one lot of each strength, when each strength is produced from a separate intermediate bulk? 1.61K viewsFDA 0 Votes 1 Ans Are differences in the capsule shell (i.e., imprint, color, size, etc.), allowed in cases where a multi-strength capsule product is dose-proportional across all strengths (based on common bead blend)? 1.54K viewsFDA 0 Votes 1 Ans What are the criteria for an exception to the recommendations regarding minimum size for pilot scale for ANDA submission batches? What justification would be needed if we wanted to deviate from these guidance recommendations? 1.58K viewsFDA 0 Votes 1 Ans Are scale-up and postapproval changes (SUPAC) level one and two variations and changes permitted among the three ANDA submission batches for components and composition? 1.59K viewsFDA 0 Votes 1 Ans Can FDA provide specific examples of cases where statistical analysis is required and the type of statistical analysis needed? 1.50K viewsFDA 0 Votes 1 Ans How many batches of drug product should be tested for split-portions of scored tablets? 1.66K viewsFDA 0 Votes 1 Ans For drug products that include placebo tablets, how many batches (of placebo tablets) are required for submission? Is 6 months of stability data on the placebo tablets needed if the ANDA is submitted after the June 2014 deadline? 1.38K viewsFDA 0 Votes 1 Ans What are the recommendations for amendments and responses filed to pending ANDAs after issuance of the final FDA stability guidance? 1.66K viewsFDA 0 Votes 1 Ans What will be the expected testing time points on accelerated conditions? 1.69K viewsFDA 0 Votes 1 Ans Can the Agency clarify expectations for the storage positions for products placed into the stability program? 1.59K viewsFDA 0 Votes 1 Ans Can the split bulk solution filled into different fill volumes be considered discrete batches? 1.63K viewsFDA 0 Votes 1 Ans Can you clarify the packaging recommendations for the submission batches for blow fill-seal containers? 1.42K viewsFDA 0 Votes 1 Ans Should all three batches be stored in final proposed packaging? 1.51K viewsFDA 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? 1.45K 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? 1.66K viewsFDA 0 Votes 1 Ans What will the recommendation for secondary packaging be? 1.65K viewsFDA 0 Votes 1 Ans What are the recommendations for stability testing data of modified release dosage forms? 1.42K 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? 1.61K viewsFDA « Previous 1 2 … 6 7 8 9 10 … 75 76 Next » Question and answer is powered by anspress.net
