USA – FDA outlines process for recognizing standards for regenerative medicines
The US Food and Drug Administration (FDA) has issued final guidance describing its process for recognizing voluntary consensus standards (VCS) to spur the development...
UK – MHRA instructs health organisations to prepare now for new measures to reduce...
Healthcare organisations are being instructed by the Medicines and Healthcare products Regulatory Agency (MHRA) now to put in place a plan to implement the first phase...
Europe – Pharma groups fight proposed ban on titanium dioxide in Europe
Pharmaceutical industry groups are working to submit comments to the European Medicines Agency (EMA) to oppose a proposed ban on the use of titanium...
UK – AstraZeneca’s rare disease unit receives NICE recommendation for Wolman disease therapy in...
Alexion’s Kanuma (sebelipase alfa), which has been specifically recommended for use in patients who are aged two years or younger when administration begins, will...
USA – Stakeholders urge FDA to retain interchangeability statements on biosimilar labeling
Two major pharmaceutical industry groups opposed the US Food and Drug Administration’s (FDA) proposal to remove details about interchangeability from product labels in its...
USA – FDA issues new standards for DTC prescription drug ads
The US Food and Drug Administration (FDA) published its final rule changing how companies must present the “major statement” in direct-to-consumer (DTC) TV and...
USA – Global Pharma’s eye drops contaminated with “filth” while Amazon made unapproved claims...
The US Food and Drug Administration (FDA) lambasted India-based Global Pharma Healthcare in a 14 November warning letter for manufacturing eye drops that have...
USA – Industry calls for revisions in FDA’s CGT manufacturing change guidance
Pharmaceutical industry and regenerative therapy groups want the US Food and Drug Administration (FDA) to take a more nuanced approach in guidance on reporting...
UK – MHRA authorises world-first gene therapy for two inherited blood disorders
Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel) is now the first licensed treatment that uses the gene-editing tool CRISPR, for which its inventors...
France – Levothyrox et médicaments à base de lévothyroxine : information concernant la disponibilité...
Depuis octobre 2017, le laboratoire Merck, à la demande de l'ANSM, importe en France la spécialité Euthyrox (identique à l'ancienne formule de Levothyrox) pour...
