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Nov 1, 20221 min read

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...

Sep 30, 20221 min read

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...

Jul 23, 20222 min read

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...