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The head of clinical pharmacology at another monitoring centre described that oftentimes the CDSCO had not reviewed the PSUR submitted by the pharmaceutical company so there was a lack of feedback or there was no time to track the post-marketing surveillance.
Companies were required to submit PSURs at specified intervals following approval of a drug.
Through the submission of PSURS and reporting of serious ADRs within a specified timeframe, companies were required to comply with the regulatory requirements for reporting ADRs to the national PV centres.
In a business making drugs based on, for example, acetylsalicylic acid, a product that has been on the market for well over 100 years, the chances are there is often no new knowledge to be gained from PSURs (Periodic Safety Update Reports) and single case handling, yet the dogged reporting and analysis still has to take place in order to maintain compliance.
Volume 9a states that drug companies may now collectively submit their PSURs, for example for generic products, rather than individually.
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- Psurtsev, Nikolai
- Psurtsev, Nikolai Demianovich