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Attached is the USFDA guidance for your ready reference. Risk Assessment is MUST. Based on the API, it may or may not require confirmatory testing. A "Risk Assessment Report" needs to be prepared and kept at the manufacturing facility. Finished Product manufacturer will sure come to API manufacturer ...

Predicate devices that were problematic and removed from the market may still be used to demonstrate "substantial equivalence" for new devices. Also, devices that were already on the market when regulation began in 1979 were grandfathered; they may be used as a predicate even though they never had to ...

As per guidance only PAS for modified release dosage form. But, if you can justify, that it does not impact the modified release pattern of the product, then very high chances that you can go for moderate change. I suggest to submit CBE-30 with the relevant technical data for the equivalency including ...

Its advisable to take course for the US regulations, if you don`t have experience in the Regulated Markets like US, Europe, Australia, etc. This gives you more confidence, when you get started working for the US companies. ------------------------------ Gaurang Bhavsar, MS, RAC Associate Director ...