TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

TGA has published advertising guidance for providers of stem cells and other human cell and tissue (HCT) products. The agency created the guidance after...
New Zealand Seeks Feedback on Safety-Focused Changes to Paracetamol Labels

New Zealand – New Zealand Seeks Feedback on Safety-Focused Changes to Paracetamol Labels

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is seeking feedback on planned changes to the warning and advisory statements for paracetamol....
Experts Pitch FDA on Policies to Improve Drug Development

USA – Experts Pitch FDA on Policies to Improve Drug Development

The US Food and Drug Administration (FDA) on Thursday heard from more than two dozen stakeholders on opportunities for the agency to promote more...
Regulators’ advice can make a difference for faster patient access to highly innovative therapies

Europe – Regulators’ advice can make a difference for faster patient access to highly...

Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies (HTAs) and patients can play a key role in delivering robust data needed...
NICE U-turn for Epidyolex in epilepsy

UK – NICE U-turn for Epidyolex in epilepsy

Initially the organisation rejected the cannabinoid prescription medicine but promised to “work with the company to resolve the economic modelling issues identified by the...
ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry

International – ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry

A recently released survey from the International Council on Harmonisation (ICH) shows pharmaceutical regulators and companies around the world are adopting and adhering to...
Administration de médicaments : la Suisse devient le pays d’Europe le plus innovant Publié le 08 novembre 2019 par Patrick RENARD

Europe – Administration de médicaments : la Suisse devient le pays d’Europe le plus...

Le rapport European Drug Delivery and Packaging publié en début d'année le prédisait déjà : de nouvelles données montrent que le rythme de l'innovation dans le...
CAT monthly report of application procedures, guidelines and related documents on advanced therapies

Europe – CAT monthly report of application procedures, guidelines and related documents on advanced...

The Committee for Advanced Therapies (CAT) held its 119th meeting on 9 – 11 October 2019. The CAT Monthly Report includes statistical data on CAT...
Administration de médicaments : la Suisse devient le pays d’Europe le plus innovant Publié le 08 novembre 2019 par Patrick RENARD

Switzerland – Swissmedic Details Plans to Align Combination Product Rules With EU

The Swiss Agency for Therapeutic Products (Swissmedic) has set out plans to align its approach to drug-device combination products with that of the EU....
REACH restrictions to watch: Microplastics, permanent make-up and cyclic siloxanes

Europe – Trade Group Calls for EU to Cut Review Times for ATMP Clinical...

The Alliance for Regenerative Medicine (ARM) has called for Europe to streamline approval of clinical trials of advanced therapy medicinal products (ATMP). ARM wants...

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