Rajkumar Gupta, M.Pharm., Regulatory Mentor at Perfect Pharmaceutical consultants Pvt Limited, dia. 1 proside professional regulatory services on GMP Audits/Training, ANDA, NDA IND, CEP, DMF, PV. PSUR, Contact perfectdossiers@ gmail.com visit: www:perfectdossier.com 40. | What is anniversary date It is the date on which DMF was accepted and with reference to DMF? | registered in DMF Database and a unique No was assigned by FDA 41. | What is development It is systematic description of the development of history? the drug through lab trials, pilot trials, and pivotal trials to. commercial production. It includes formulation development, stability studies. Impurity profiling and validation Studies. 42. | What is import Import registration is the legal permission for the registration? import of the health products in a country. 43. If FDA be relied for alll Yes. Very well, confidential technical information included CTD/DMF 44. | Does FIDA alllow changes in | Yes, FDA allows changes/variations in the technical Information information already submitted in CTD, Please see submitted in CTD? SUPAC guidelines When a company recalls | No. It’s not an real recall the expired products from its warehouse for replacement with fresh stock, does it needs to be informed to FDA. ‘What is orange book? It isa database maintained by FDA to share following information publically New Drug Products for which patent has not expired Generic Drug products Drug product withdrawn from the market It provides comprehensive information covering generic name, brand name , patent details, applicants name and corresponding date and month 47. | What are public The public assessment reports are reports on assessment reports? Who | drugs, pharmaceuticals and manufacturing s publishes such reports? _| published by drug authorities in many countri Why? for building transparency about their functions. ‘These reports are designed to protect the confidential or restricted aspect of the drug products 48. | What is Pharmacopeia Pharmacopeia forum is a body annexed to USP. It forum? What information | publishes changes, guidelines, news, information, does it provide? draft monographs, new approved monographs on monthly basis. It has open access. © Copyright by Mr. Rajkumar Gupta, August 2014 india. All rights reserved.