All Regulatory Area articles
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EditorialSustainable pharmaceuticals
Regulatory Rapporteur July/August 2024 | Volume 21 | No.7 In this bumper July/August edition of Regulatory Rapporteur, we focus on sustainability and, in many aspects, we build upon our June theme of access to medicines. Sustainability in pharmaceuticals encompasses ...
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Industry newsBurkina Faso gives R21 malaria vaccine approval in children
Burkina Faso’s regulatory agency – Agence Nationale de la Regulation Pharmaceutique – has approved the R21/Matrix-M malaria vaccine for children.
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Industry newsGlobal life sciences consultancy created from SSI/NDA merger
US-based SSI Strategy buys Sweden-based regulatory affairs consultancy NDA Group AB; Strömquist stays on as President of NDA unit.
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CPD SupplementQualification of stride velocity endpoint in Duchenne Muscular Dystrophy
In April 2019, the Committee for Medicinal Products for Human Use (CHMP) issued a qualification opinion on stride velocity as an endpoint in clinical studies of medicines for the treatment of Duchenne Muscular Dystrophy (DMD).[1] Mutations in the dystrophin gene cause this inherited, x-linked disorder which causes progressive muscle weakness ...