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UK MHRA: 150-Day Assessment for National Applications
Recently the UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated their "150-day assessment for national applications...

Sharan Murugan
Nov 1, 20221 min read
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UK MHRA: European Commission Decision Reliance Procedure (EC DRP) Extension
Earlier today (30 September 2022) to ensure British people have timely access to medicines, the European Commission Decision Reliance...

Sharan Murugan
Sep 30, 20221 min read
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USFDA's Guidance: Failure to Respond to an ANDA Complete Response Letter Within the Timeframe
On 22-July 2022, USFDA released multiple guidance among them one is "Failure to Respond to an ANDA Complete Response Letter Within the...

Sharan Murugan
Jul 23, 20222 min read
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