REGISTRATION PROCESS OF GENERIC DRUGS IN USFDA

Mamatha M*, Kranthi Kumar B, Ch. Ramya Sree, Teja D, Sravani M, Elphine Prabhahar A, Rama Rao N

Regulatory involvement in the generic drug development hastens the drug approval process which directly or indirectly accelerated the launching of drug into the market. The regulatory documents whether in-house of documents to be submitted to regulatory authorities should be carefully reviewed by the skilled personal to minimize the queries raised by the regulatory agencies and speed up the approval process. Sponsors must ensure submissions meet the USFDA requirements for format and content.