The association between progesterone and meningioma has been known or knowable for decades, particularly for sophisticated pharmaceutical corporations like Defendants engaging in FDA-required post-market surveillance of their products for potential safety issues. That duty includes an obligation to keep curre...
EMA recommends revised labeling and guidance for pioglitazone-containing products - European Pharmaceutical Review
Short Overview of FDA Regulations and Guidance for the Traditional Chinese Medicine (TCM) According to offical website of FDA, here is a list of pharmaceutical products approved by FDA in 2019: No.Drug NameActive IngredientApproval DateFDA-approved use on approval date* ...
The members of the Agency's Management Board and scientific committees, and its experts and staff are not permitted to have financial or other interests in the pharmaceutical industry that could affect their impartiality. Each member and expert make an annual declaration of their financial interests....
After this effective date, any biotech or pharmaceutical company in the EU seeking marketing authorisation of medicinal products will need to implement this guideline to ensure compliance of individuals accessing or using electronic data. This whitepaper provides you with: Overview of the evolution...
法国:Arrow Generiques,Biogaran,Cristers,Eg Labo Laboratoires Eurogenerics,Krka, D.D., Novo Mesto,山德士,Teva Santé,赛诺菲,诺华,Ipsen Pharma,迈兰,Laboratoires Alter,Evolupharm,兰伯西,Zydus France,Elpen Pharmaceutical Co. Inc.,Laboratorios Liconsa, S.A. ...
Evan Richardson began his career in the pharmaceutical industry 18 years ago, and today he is the Senior Director of Transparency and Disclosure services at Certara. His experience includes drugs, biologics, and medical devices and he has worked for both service providers and in industry across org...
Decision trees for the selection of sterilisation methods (EMEA/CVMP/065/99) which is an annex to the note for guidance: Development pharmaceutics for veterinary medicinal products (EMEA/CVMP/315/98). 本指南取代了灭菌方法选择的决策树文件(CPMP / QWP / 054/98 ),该文件是药品研发指 南说明(CPMP...
8 13. What is the approach for new and ongoing marketing authorisation applications (MAA)? (UPDATED) 8 14. Are biological products containing excipients potentially at risk of contamination with Nitrosamines in the scope of the review? 9 15. What to do if after completing step 1 and /or ste...
This additional EMA GMP certificate was issued following a remote inspection conducted by Poland's Chief Pharmaceutical Inspectorate in April 2021. The comprehensive inspection covered not only the Quality Control (QC) testing of a Master Cell Bank (MCB) and Working Cell Bank (WCB) used for the ...