USA Three FDA Final Guidance’s on Electronic Submission of Safety Reports Three FDA final guidance’s address electronic submissions for reporting adverse reactions — one for investigational new drug application (IND) safety reports, one fo…

USA FDA Modernizes Informed Consent Guidance, Aligning With Common Rule Changes The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations …

Rare diseases are a complex of over 5000 pathologies representing 10% of the entire human pathology. The European Commission decided to consider those pathologies whose incidence does not exceed 5 cases per 10,000 inhabitants as rare diseases. Ra…

AUSTRIA User Manual for Marketing Authorisation and Lifecycle Management of Medicines BASG published User Manual for Marketing Authorisation and Lifecycle Management of Medicines. How to login, how to apply, how to reply to communication,…

Asia China NMPA Tightens Regulation on Outsourced Manufacturing for MAHs NMPA issued the Notice on Enhancing the Supervision and Management of Outsourced Manufacturing for Drug Marketing Authorization Holders (MAHs) (referred to as the …

USA Thousands of Comments Pour in on FDA Plan to Regulate Laboratory-Developed Tests As the public comment period closes Monday on the FDA’s rule to regulate laboratory-developed tests (LDT), the FDA has received more than 2,100 remarks – i…