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Industry Insights
Industry Feed
- Hydroxyethyl-starch solutions for infusion recommended for suspension from the market, CMDh, 25/02/2022
Update as of 25 May 2022:On 24 May 2022, the European Commission issued a legal decision confirming the suspension of the marketing authorisations of HES...
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2022, CHMP, 24/06/2022
Nine new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended nine medicines for approval at its June 2022 meeting.The ...
- First gene therapy to treat severe haemophilia A, CHMP, 24/06/2022
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) for the...
- EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17, CHMP, 23/06/2022
EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use in...
- EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17, PDCO, 23/06/2022
EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use in...
- EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU, CHMP, 23/06/2022
EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in the primary vaccination of...
- CBD Novel Food Assessment Interrupted Due to Data Gaps
- FDA Form 483 due to Insufficient Investigations after Out-of-Specification (OOS) Dissolution Results
- EMA: Another Update of the Q&As on Parallel Distribution
- Benefit-Risk Assessment for Product Quality Evaluation
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