This draft guidance provides recommendations to applicants of human prescription drug and biological products on appropriate placement and content of drug interaction (DI) information in labeling as described in the regulations for the content and format of...
Title Consultation Period Category 2. The Accreditation Scheme for Conformity Assessment (ASCA) Program Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff End date: 23rd December 2024 Guidance Posted...
A la lecture du PLFSS 2025, le Snitem dénonce un montant d’économies relatif aux baisses de prix non soutenable pour les entreprises du dispositif médical et à l’opposé des objectifs de réindustrialisation et d’innovation portés...
This meeting between European Medicines Agency (EMA) and EFPIA is organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations. The purpose of the meeting is to exchange views and promote...
This meeting between European Medicines Agency (EMA) and Vaccines Europe is organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations. The purpose of the meeting is to exchange views and...
EMA is hosting the thirteenth industry stakeholder platform on the operation of the centralised procedure for human medicines. This will be the thirteenth in a series of regular meetings between regulators and representatives of industry...
This meeting between European Medicines Agency (EMA), IPFA and PPTA is organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations. The purpose of the meeting is to exchange views and...
The European Medicines Agency (EMA) organised a hybrid SME (small and medium-sized enterprises) info day on 18 October 2024. The SME info day is a training event dedicated to small and medium-sized enterprises in the...
Since 2022, the European Medicine Agency’s (EMA) Industry Standing Group (ISG) meets four times per year to enable an exchange of views between the Agency and stakeholders in the pharmaceutical and medical device industries. The group...
The FDA has issued a draft guidance which provides recommendations for the development of drug and biological products for the treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC) and is intended for pharmaceutical...
