Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What forms do I use to request drugs using the PIP? 1.55K viewsFDA 0 Votes 1 Ans Is it legal to import medicines into the U.S. from other countries? 1.52K viewsFDA 0 Votes 1 Ans What are the drug interactions, side effects, and/or adverse events associated with a certain medicine? 1.51K viewsFDA 0 Votes 1 Ans Do the small scale batches need to be manufactured in accordance with all CGMP regulations, or is it acceptable to manufacture the small scale batches in a research setting? 1.58K viewsFDA 0 Votes 1 Ans Should the small scale batches meet the same finished product specification as the pilot scale batches? 1.48K viewsFDA 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 « Previous 1 2 … 141 142 143 144 145 … 283 284 Next » Question and answer is powered by anspress.net
