The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
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UK Medicine and Healthcare products Regulatory Agency (MHRA)
Professor Tom Clutton-Brock was awarded an MBE for his work in approving novel ventilators for the UK’s National Health Service during the COVID-19 pandemic.
Certificates of Compliance or Attestation of Conformity have no legal standing under UK Medical Device Regulations 2002
The UK’s MHRA has stated that manufacturers must instead issue a Declaration of Conformity to Directive 93/42/EEC and register their Class I medical device with an EU Competent Authority.
The European Medicines Agency (EMA) said its assessment of the conditional marketing authorisation (CMA) application will be performed under a reduced timeframe, with a decision potentially delivered in weeks.
Dr Abhishek Dadhich rounds up how the Indian pharmaceutical market has been impacted by the coronavirus pandemic and the steps the country’s government could take to overcome these setbacks.