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  • Regularoty Affair Pharma 6

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    Jalwaz Tihami
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    Regularoty affair pharma 6

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    6 views1 page

    Regularoty Affair Pharma 6

    Uploaded by

    Jalwaz Tihami

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    Rajkumar Gupta, M.Pharm. , Regulatory Mentor at Perfect Pharmaceutical consultants Pvt Limited, India. 1 provide profes ional regulatory services on cGMP Audits Training. ANDA, NDA IND, CEP, DMF. PV. PSUR. Contact perfectdossiers@ gmail.com vist: www:perfecidossiercom ‘MA of Biological products jin US? 49. | What is the purpose of To understand the likely impurities which can Forced Degradation iginate the drug product Studies? » verify the validity of the current analytical methods for detecting impurities 50. | Why CT and BE require To restrict unethical/incomplete/irrational trials pre registration with Regulatory authorities |__| before initiation? 51. | Do LD50 testing for NO LDS0 studies for the drug safety have been studying drug safety is still | stopped by all regulatory authorities. valid? 52. | Can I file ANDA before the | Yes. You can file an application, However, the expiry of the relevant marketing authorization will be granted only after Patent? the expiry of the originators patent. 53. | Can I withdraw my Yes. Itis permitted. marketing authorizations | voluntarily? 54, | Do new drugs require BE | The BE studies cannot be carried on New Drugs. studies? You can only conduct BA studies on them 35. | Does both BA &BE studies. | ANDA requires on BE studies. are needed for ANDA Products? 56. | Is it true that regulations, | Only the final regulations have force o law. The draft regulations and draft regulations are drafted for comments only. guidance documents have | The Guidance documents are meant for clarifying the force of law? the regulations. 57. | Name the application for | BLA ‘Name the authorization Agreement, Determination, Pre-IDE, Pre-PMA, procedures for medical | and PMA day-100,510(k) devices in US 59. | Does FDA advisory Each committee provides its Independent views committees provide on regulations, independent views Or generalized view on regulations ‘Name the regulations pertaining to stability studies for clinical trial products

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