Dilip Ghava, Bhargav Shilu, Gaurav Shrivastava and CK Sudhakar
Posters: Pharmaceut Reg Affairs
A new animal drug is defined, in part as any drug intended for use in animals other than man, including any drug intended for use in animal feed but not including the animal feed, the composition of which is such that the drug is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of the drug. There are three different types of new drug applications. Form FDA 356v is used to submit an application. 1. NADAs and supplements 2. ANADAs and supplements 3. CNADAs USER FEES The Animal drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) authorize FDA to collect fees for animal drug applications. These fees provide funding for increased review staff, training and development for staff members, and for refining business processes and developing policies targeted at more efficient review.
Dilip ghava has done his B.pharm from R.T.M.Nagpur University,Nagpur. He is currently doing his M.pharm in Quality assurance sem-3, Department of Pharmaceutical sciences, Saurashtra University, Rajkot. He has attended IPC Conferences, ISP Conferences and many more National & International conferences, I Presented Many papers in above conferences on the subjects like ?UPLC, PAT, DOE? and many more.
Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report