Posts Tagged ‘Guidelines’

India Adopts Long Waited Medical Device Guidelines

India Adopts Long Waited Medical Device Guidelines

One of the leading emerging Pharmaceutical markets, India has completed its long anticipated medical device guidelines. The guidelines are set to ease regulation of medical device manufacturing and development by freeing the sector from rules developed for the pharmaceutical industry.

So far, a lack of fully committed regulations addressing the greater part of medical devices left the industry operating under regulation designed…

FDA Issues Draft Guidance on PBPK Analysis

FDA Issues Draft Guidance on PBPK Analysis

US regulatory authority Food and Drug Administration (FDA) on 1st December 2016 released a new draft guidance designed to assist sponsors report physiologically based pharmacokinetic (PBPK) analyses to the agency in a standard format.

PBPK Analyses

With respect to FDA, “PBPK analysis makes use of models and simulations that combine physiology, population, and drug characteristics to mechanistically explain the pharmacokinetic (PK) and/or pharmacodynamic…

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US FDA Finalizes Guidance on Post-market Device Surveillance

US FDA Finalizes Guidance on Post-market Device Surveillance

US regulatory authority Food and Drug Administration (FDA) on 27th May finalized guidance (5 years following draft guidance was first launched) for device manufacturers on its interpretation of the law with respect to post-market surveillance of specific class II or class III devices.

The guidance occurs as the Government Accountability Office (GAO) stated previous October that 90 percent of the post-market surveillance…

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