Regulatory Updates-May 2020
EMA starts rolling review of remdesivir for COVID-19 Read More… EMA: CHMP recommended the suspension of all ranitidine medicines in the
Category: Regulatory Updates
Regulatory Updates-April 2020
FDA: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Read More… EMA: chloroquine
Regulatory Updates – March 2020
FDA: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Read More… FDA: Product-Specific guidance for generic
Regulatory Update – Feb 2020
FDA: Promotional Labelling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers (Draft guidance) Read More…
Regulatory Update – January 2020
EC: Guidance on cybersecurity for medical devices Read More… Finland: Supervision of medical devices will be transferred from Valvira to