USA – FDA asks manufacturers to develop risk management plans to avert shortages

The US Food and Drug Administration (FDA) has issued draft guidance that spells out which types of drugs and medical devices are vulnerable to...

Europe – First therapy to treat two types of Niemann-Pick disease, a rare genetic...

EMA has recommended granting a marketing authorisation in the European Union (EU) for Xenpozyme (olipudase alfa), a therapy for the treatment of non-central nervous system (CNS)...

Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...

Nine new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its May 2022 meeting. A recommendation for marketing authorisation was adopted...

Europe – Synchron Research Service: suspension of medicines over flawed studies

EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of several generic medicines tested by Synchron Research Services, a contract research organisation (CRO) located...

Europe – First therapy to treat rare genetic nervous system disorder AADC deficiency

EMA has recommended granting a marketing authorisation in the European Union (EU) for Upstaza (eladocagene exuparvovec), a therapy for the treatment of adult and paediatric patients...

Europe – First treatment for children with Progeria or progeroid like syndromes (rare premature...

EMA has recommended granting a marketing authorisation in the European Union (EU) under exceptional circumstances for Zokinvy (lonafarnib), a treatment for patients with a genetically confirmed diagnosis of...

Europe – EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine

The COVID-19 vaccine candidate can now move from the initial rolling review process to the formal review process, which is overseen by the Committee...

UK – NICE recommends app-based treatment for insomnia over sleeping pills

NICE has recommended Sleepio as an effective alternative to sleeping pills. The move would save the NHS money as well as reducing prescriptions of...

Canada – Update : Validation rules for regulatory transactions provided to Health Canada in...

Health Canada has updated the validation rules for regulatory transactions submitted in the non-eCTD format. These rules are built in accordance with the information...

USA – FDA updates guidance on evaluating out-of-specification results for drugs

The US Food and Drug Administration (FDA) has revised its 16-year-old final guidance on procedures for reviewing out-of-specification (OOS) results in the laboratory, including...

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